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How Surgical Masks are Made, Tested and Used


Surgical masks, once simply a strip of cloth tied around the face of a doctor or nurse, are today manufactured using non-woven fabrics made from plastics like polypropylene to filter and protect. They are also available in many different styles and grades depending on the level of protection the user requires. Looking for more information on surgical masks to meet your medical sourcing needs? We’ve created this guide outlining some basics about these masks as well as how they’re manufactured. If you’re interested in finding out more information about how respirators, gowns, and other personal protection equipment is made, you can also visit our overview of how PPE is manufactured

Here’s what we’ll be going over:

  1. What are Surgical Masks Used for?
  2. Types of Masks
  3. C.D.C. Updated Guidelines for Mask Usage
  4. How are Surgical Masks Made?
  5. Surgical Mask Tests
  6. Can Any Manufacturer Become a Surgical Mask Manufacturer?
  7. Sourcing for Mask Materials 

What are Surgical Masks Used for?

Surgical masks are designed to keep operating rooms sterile, preventing germs from the mouth and nose of a wearer from contaminating a patient during surgery. Although they have seen a rise in popularity among consumers during outbreaks such as the coronavirus, surgical masks are not designed to filter out viruses, which are smaller than germs. For more on which types of masks are safer for medical professionals dealing with illnesses such as the coronavirus, you can read our article on the top CDC-approved suppliers.

It should be noted that recent reports from Healthline and the CDC show that masks featuring valves or vents are more likely to spread infection. The masks will provide the same protection for the wearer as an unvented mask, but the valve does not block viruses from coming out, which can enable someone unaware they are infected to spread the virus to others. It’s also important to note that a face shield without a mask is equally able to spread the virus

Types of Masks

There are four levels of ASTM certification that surgical masks are classified in, depending on the level of protection they provide to the person wearing them:

  • Minimum protection face masks are meant for short procedures or exams that won’t involve fluid, spray, or aerosol.
  • Level 1 face masks often feature ear loops and are the general standard for both surgical and procedural applications, with a fluid resistance of 80 mmHg. They’re meant for low-risk situations where there will be no fluid, spray, or aerosol.
  • Level 2 masks, with 120 mmHg fluid resistance, provide a barrier against light or moderate aerosol, fluid, and spray.
  • Level 3 face masks are for heavy possible exposure to aerosol, fluid and spray, with 160 mmHG fluid resistance.

It should be noted that surgical masks are not the same as surgical respirators. Masks are made to act as barriers to splashes or aerosols (such as the moisture from a sneeze), and they fit loosely to the face. Respirators are made to filter out airborne particles such as viruses and bacteria, and create a seal around the mouth and nose. Respirators should be used in cases when patients have viral infections or particles, vapor, or gas are present.

Surgical masks are also not the same as procedural masks. Procedural masks are used in clean environments in hospitals including intensive care and maternity units, but they are not approved for sterile environments such as the operating room.

CDC Updated Guidelines on Mask Usage

As of November 2020, the CDC has revised its guidelines on the use of masks to allow hospitals and other healthcare centers to stretch resources during this time of extreme demand. Their plan follows a series of steps for increasingly urgent situations from standard to crisis operations. Some emergency measures include:

  • Canceling elective procedures where face masks would be required.
  • Removing freely available masks from public areas and only issuing them to people coming in without masks to monitor their consumption.
  • Extended use of face masks, including wearing the same mask while seeing multiple patients. It’s important to note the mask is to be disposed of if it becomes soiled, damaged, or difficult to breathe through. Additionally, the wearer cannot touch the outside of the mask. Wearers should only remove the mask once they’re away from the patient care area.
  • Using masks past the manufacturer sell-by date, as long as they aren’t damaged.
  • Limited reuse of face masks, where they are taken off and put back on between seeing patients. This should only be done for masks that aren’t soiled, damaged, or difficult to breathe through. Masks should be stored while folded inward to avoid contamination, and tie back masks should not be used for this. Wearers should remove them only once they’re away from the patient care area.
  • For extreme situations, when there are no masks left, the CDC recommends healthcare workers vulnerable to the virus be excluded from working with potentially infected patients, and others wear face shields and cloth masks.

How are Surgical Masks Made?

Surgical face masks are made with non-woven fabric, which has better bacteria filtration and air permeability while remaining less slippery than woven cloth. The material most commonly used to make them is polypropylene, either 20 or 25 grams per square meter (gsm) in density. Masks can also be made of polystyrene, polycarbonate, polyethylene, or polyester.

20 gsm mask material is made in a spunbond process, which involves extruding the melted plastic onto a conveyor. The material is extruded in a web, in which strands bond with each other as they cool. 25 gsm fabric is made through meltblown technology, which is a similar process where plastic is extruded through a die with hundreds of small nozzles and blown by hot air to become tiny fibers, again cooling and binding on a conveyor. These fibers are less than a micron in diameter. 

Surgical masks are made up of a multi-layered structure, generally by covering a layer of textile with non-woven bonded fabric on both sides. Non-wovens, which are cheaper to make and cleaner thanks to their disposable nature, are made with three or four layers. These disposable masks are often made with two filter layers effective at filtering out particles such as bacteria above 1 micron. The filtration level of a mask, however, depends on the fiber, the way it’s manufactured, the web’s structure, and the fiber’s cross-sectional shape. Masks are made on a machine line that assembles the nonwovens from bobbins, ultrasonically welds the layers together, and stamps the masks with nose strips, ear loops, and other pieces.

Completed masks are then sterilized before being sent out of the factory.

Surgical Mask Tests

Once surgical masks are made, they must be tested to ensure their safety in various situations. There are five tests they must be put through:

  1. Bacteria filtration efficiency in vitro (BFE). This test works by shooting an aerosol with staphylococcus aureus bacteria at the mask at 28.3 liters per minute. This ensures the mask can catch the percentage of bacteria it’s supposed to.
  2. Particle Filtration Efficiency. Also known as the latex particle challenge, this test involves spraying an aerosol of polystyrene microspheres to ensure the mask can filter the size of the particle it’s supposed to.
  3. Breathing resistance. To ensure the mask will hold its shape and have proper ventilation while the wearer breathes, breathing resistance is tested by shooting a flow of air at it, then measuring the difference in air pressure on both sides of the mask.
  4. Splash resistance. In splash resistance tests, surgical masks are splashed with simulated blood using forces similar to human blood pressure to ensure the liquid cannot penetrate and contaminate the wearer.
  5. Flammability. Since several elements of an operating room can easily cause fire, surgical masks are tested for flammability by being set on fire to measure how slowly it catches and how long the material takes to burn. ASTM levels 1, 2, and 3 are all required to be Class 1 flame resistant.

Can Any Manufacturer Become a Surgical Mask Manufacturer?

It is possible for a generic manufacturer, such as a garment factory, to become a surgical mask manufacturer, but there are many challenges to overcome. It’s also not an overnight process, as products must be approved by multiple bodies and organizations. Hurdles include:

  • Navigating test and certification standards organizations. A company must know the web of test organizations and certification bodies as well as who can give them which services. Government agencies including the FDA, NIOSH, and OSHA set protection requirements for end users of products like masks, and then organizations such as the ISO and NFPA set performance requirements around these protection requirements. Then test method organizations such as ASTM, UL, or AATCC create standardized methods to ensure a product is safe. When a company wants to certify a product as safe, it submits its products to a certification body such as CE or UL, which then tests the product itself or uses an accredited third party testing facility. Engineers evaluate the test results against performance specifications, and if it passes, the organization puts its mark on the product to show it’s safe. All of these bodies are interrelated; employees of certification bodies and manufacturers sit on the boards of standards organizations as well as end users of the products. A new manufacturer must be able to navigate the interrelated web of organizations that handle its specific product to ensure the mask or respirator it creates is properly certified.
  • Navigating government processes. The FDA must approve surgical masks, which under pre-pandemic circumstances could be a long process, especially for a first-time company that hasn’t gone through the process before. However, the FDA has recently relaxed rules to allow some companies to get emergency use authorizations for surgical masks. It is also willing to work with manufacturers pivoting from other products. More information as of April 2020 can be found here.
  • Knowing the standards to which a product must be manufactured. Manufacturers need to know the testing that a product will go through so they can make it with consistent results and ensure it’s safe for the end user. The worst case scenario for a safety product manufacturer is a recall because it destroys their reputation. PPE customers can be difficult to attract since they tend to stick to proven products, especially when it could literally mean their lives are on the line.
  • Competition against large companies. Over the past decade or so, smaller companies in this industry have been acquired and consolidated into larger companies like Honeywell. Surgical masks and respirators are highly specialized products that larger companies with experience in this area can manufacture more easily. Partly from this ease, larger companies can also make them more cheaply, and therefore offer products at a lower price. Additionally, the polymers used in creating masks are often proprietary formulas.
  • Navigating foreign governments. For manufacturers specifically wishing to sell to Chinese buyers in the wake of the 2019 coronavirus outbreak, or a similar situation, there are laws and government bodies that must be navigated.
  • Getting supplies. Currently there are mask material shortages, especially with melt-blown fabric. A single melt-blow machine can take months to make and install due to its need to consistently produce an extremely precise product. Because of this it has been difficult for melt-blown fabric manufacturers to scale up, and the massive global demand for masks made from this fabric has created shortages and price hikes.

Sourcing for Mask Materials

While materials for surgical masks have undergone shortages due to the ongoing pandemic, open-source patterns and instructions for masks made of more common materials have been popping up across the internet. Although these are meant for DIYers, they can also be used as a starting point for commercial patterns and production. We’ve found three mask pattern examples and provided links to sourcing categories on Thomasnet.com to help you get started.

Regional Medical Center

The Olson Mask: This mask is designed to be donated to hospitals, which will add the hair ties and waxed string for a better fit to the individual healthcare worker, as well as inserting the .3 micron filter.

FreeSewing.org

The Fu Face Mask: This website includes an instruction video for how to make this face mask. The pattern requires you to measure the circumference of your head.

Sew It Online

Cloth Mask Pattern: Sew It Online’s mask includes the pattern design on the instructions. Once the user prints the instructions out, they can simply cut out the pattern and start working.

Conclusion

Now that we’ve outlined details on the types of surgical masks, how surgical masks are made, and challenges to companies trying to break into the field, we hope this will enable you to source more effectively. If you’re ready to start shortlisting suppliers, we invite you to check out our Supplier Discovery page, which has detailed information on over 90 suppliers of surgical masks.

The purpose of this document is to collect and present research on the way surgical masks are manufactured. While we endeavor to curate and create the most up-to-date information, please note that we cannot guarantee 100% accuracy. Please also note that Thomas does not provide, endorse, or guarantee any third-party product, service or information. Thomas is not affiliated with the vendors featured on this page and is not responsible for their products and services. We are not responsible for the practices or the content of their websites and apps.

Sources:

  1. Journal of Academia and Industrial Research
  2. Textile Learner
  3. Nonwovens Excellence Platform
  4. Nelson Labs
  5. ASTM
  6. Canadian Centre for Occupational Health and Safety
  7. Becker’s Hospital Review
  8. Crosstex
  9. Infection Control Products
  10. NPR
  11. U.S. National Library of Medicine
  12. New York Times
  13. Entrepreneur India
  14. Nonwoven Tools

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Surgical Face Mask: 15 Things You Should Know Before Buying


Over the last few months, we’ve seen a great discussion regarding face masks and their effectiveness in the fight against COVID-19. The Centers for Disease Control and Prevention has alone changed its face masks recommendations several times.

The CDC advised at first that masks should be worn by only those who have symptoms, and then they stated that everyone should wear a face mask outside of their home. This has stirred up the world and created a high demand for face masks.

People started selling and buying masks everywhere, without really knowing whether they are certified, approved by the WHO and FDA, or whether they’re efficient.

Soon, the rumors about surgical masks being highly effective spread, and the demand for these masks was at its all-time-high.

However, there was a problem, and is there even today; there’s wasn’t and isn’t enough surgical masks for everyone, and the priority always shifts to healthcare workers and first responders.

Even today, the CDC urges people to not wear surgical masks, for logical reasons; doctors, nurses, and other healthcare workers need those masks the most. But if you do come across a surgical mask and decide to wear it, here’s what you should know!

But, before we start, make sure to check out Dr. Richard Davis conducting two demonstrations about how wearing a mask can block respiratory particles. In the first demonstration, he talked, sang, coughed, and sneezed without a mask, and in the other, he used a mask. The result surely speak for themselves;

Remember that wearing a mask, regardless of what kind, can lower your risk of getting infected or infecting someone else. Wearing a mask, alongside other safety measures can save lives!

Surgical Face Mask: 15 Things To Know Before Buying

  • Surgical masks are disposable, loose-fitting devices used to prevent virus transmission and potential contamination of one’s nose, mouth, and respiratory system.
  • Surgical masks are FDA-regulated masks, intended for medical application.
  • Surgical masks, both in the USA and EEA need to conform to the ASTM F2100 and EN 14683 standards. In both standards, there needs to be Bacterial Filtration Efficiency (BFE) higher than 95% with particles of size higher than 3.0 μm.
  • Surgical masks should have at least three layers and be made from nonwoven fabric via the melt blowing process.
  • The CDC and the WHO recommend surgical masks only be worn by health care staff, and the general public should opt for cloth or disposable face masks.
  • Several emerging studies show that surgical masks can be as effective against COVID-19 as N95 or KN95 masks.
  • Surgical masks can cause skin irritation, rashes, acne breakout, breathing difficulties, and overall irritability.
  • According to CDC, surgical and face masks should wear anyone over the age of 2, provided they don’t have specific illnesses and conditions which prevent them from wearing a mask.

1. What Are Surgical Face Masks?

Surgical masks are loose-fitting, disposable devices that are designed and created to prevent potential contaminants from entering your mouth and nose.

These masks are regulated under 21 CFR 878.4040, as stated by the FDA. These masks are created to have a one-time use and are not to be shared.

Often referred to as face masks, surgical masks can also be labeled as isolation, dental, and medical procedure masks (but not all face masks are regulated as surgical masks). Surgical masks may come with or without a face shield.

Medical protective mask
Image Source: Terry Cralle, RN

2. Are Surgical Face Masks Tested And Approved?

Surgical masks are FDA-regulated masks, approved for medical purposes and use. These masks are designed to be fluid resistant and ensure the proper protection against hazardous bodily fluids (droplets, splashes, sprays – coughing, sneezing).

However, surgical masks are not certified as respirator masks, and shouldn’t be confused with respirator masks.

In the Europe Economic Area (EEA), surgical masks have to be certified through the CE marking process, before commercialization (a product needs to conform with health, safety, and environmental protection before sold within EEA). This means that the masks need to be made with respect to Medical Device Regulations, or directives for medical devices.

Surgical masks, both in the USA and EEA need to conform to the ASTM F2100 and EN 14683 standards. In both standards, there needs to be Bacterial Filtration Efficiency (BFE) higher than 95% with particles of size higher than 3.0 μm.

3. What Is The Purpose Of A Surgical Face Mask?

Surgical masks are intended to protect the wearer from any form of hazardous bodily fluid if worn properly. The masks are also intended to create a barrier between the wearer of the mask and the particles like bacteria, viruses, or fluid that may contain bacteria or viruses.

Surgical masks may reduce the risk of exposure to contaminants, saliva, and respiratory secretions of others, or may lower the risk of you exposing other people to the same contaminants and bodily fluids.

4. How Are Surgical Face Masks Made?

Surgical masks are made of nonwoven fabric, created using a melt blowing process. These masks are made in different thickness levels, so they have different protective efficiency.

That is why it is important to bear in mind that not every surgical mask is made equally the same, nor do they have the same protective efficiency.

Surgical masks are often three-ply (have three layers). The three-ply material is made from melt-blown polymer, placed between the nonwoven fabric. The masks can often expand in such a way to cover the area from the nose to the chin, and they are secured to the head with either head ties, elastic straps or ear loops.

Surgical Masks have 3 layers
Image Source: Terry Cralle

5. Who Should Wear A Surgical Face Mask?

The CDC and the WHO recommend surgical masks only to be worn by health care staff during the evaluation of and care for suspected or confirmed COVID-19 patients, as stated by Health Departments across the US.

However, if someone does have a surgical mask, they can wear it. But, it is better if they choose alternative masks, especially if they’re asymptomatic.

6. Are Surgical Masks Efficient?

Surgical masks are effective when it comes to blocking splashes and large-particle droplets.

However, they do not provide complete protection from germs, bacteria, viruses, and other contaminants, because these masks are loose-fitting.

There’s always space between the mask and the face, which doesn’t make surgical masks 100% efficient. Surgical masks DO NOT filter or block very small airborne particles that can be transmitted by sneezing, coughing, or during medical procedures.

However, with respect to some infections, like influenza, surgical masks appear just as effective as N95, KN95 respiratory face masks, and FFP masks.

Collection efficiency of surgical masks can range from 10% to 90%, depending on the mask manufacturer and the test parameters used during the NIOSH certification.

Studies show that most of the surgical masks fail the OSHA-accepted qualitative fit tests, and there is usually a 12% to 25% of leakage with these masks.

7. Are Surgical Masks Effective Against COVID-19 (Coronavirus)?

Three randomized studies have shown that surgical masks can be just as effective as N95 or KN95 respiratory face masks against COVID-19, only if worn properly and if the loose-fit is fixed as much as possible.

These masks, just like the respiratory face masks can reduce hand-to-face contact, as well as lower the risk of getting infected or infecting someone else.

8. How Is The Performance Of A Surgical Face Mask Evaluated?

The performance of a surgical mask is evaluated using the parameters of filtrations, exposure, mask airflow resistance, liquid penetration resistance, air and water vapor permeability, and water repellency.

9. Are Surgical Masks Disposable?

Surgical masks are made for one-time use and aren’t intended to be used more than once. They are also made to be disposable.

If you notice that a mask is damaged, or if the breathing through the mask becomes difficult, you should remove the mask and dispose of it safely.

Make sure to dispose of the mask using a plastic bag, which you will throw in the trash. It is essential you wash your hands with soap or alcohol-based sanitizer (at least 60% alcohol) after handling a used surgical, or any kind of mask.

10. How To Recognize A Certified Surgical Face Mask?

Certified surgical masks are supposed to come with labeling that accurately describes the product as a surgical mask. There should also be a list of the body contacting materials, as well as the uses for antimicrobial and antiviral protection, infection prevention, protection during a surgical procedure, or any other related uses.

However, it is important to know that the FDA does NOT issue any kind of certification to demonstrate a manufacturer is in compliance with the FDA requirements.

The FDA also does NOT have a list of all counterfeit or fraudulent products.

They also do NOT have a list of mask suppliers.

11. What Are The Limitations Of Surgical Masks?

  • Limited supply due to high demand.
  • Have to be safely handled; these masks shouldn’t be touched, and if touched, the person wearing/touching the mask needs to wash their hands thoroughly.
  • Surgical masks cannot be washed.
  • Surgical masks cannot be reused, even if the FDA and CDC advise possible extended use or reuse as a part of the protective measure strategy.
  • Surgical masks need to be discarded immediately if there are signs of damage or deformity if the mask is wet, dirty, if breathing becomes difficult, if the mask is contaminated by blood, saliva, respiratory secretion, or any other bodily fluid.

12. Are Surgical Masks Harmful?

study shows that heart rate, microclimate (temperature and humidity), and general bodily functions are significantly affected when wearing a surgical mask.

High breathing resistance makes it difficult for individuals to breathe and take in sufficient amounts of oxygen.

A shortage of oxygen is proven to affect the nervous system and heart rate, which can further cause stress and reduce work tolerance. There is further evidence of surgical masks causing skin irritation, thermal stress, itchiness, fatigue, and overall discomfort while wearing the mask.

13. Should Children Wear Surgical Masks?

Surgical or face masks should NOT be worn by children younger than two, due to suffocation risk. However, children older than the age of two should be wearing surgical or facial masks, according to the latest CDC update. Even children with special health conditions, with rare exceptions, are supposed to wear facial masks.

However, children who are unable to remove a face mask on their own should NOT wear one in the first place. Children should wear a face or surgical mask in child care, at school, or in case they cannot stay 6 feet away from others.

14. Where Can I Buy Certified Surgical Face Masks?

  • Amazon – there seem to be numerous stores on Amazon that sell legit, certified, and registered surgical, disposable masks. You can buy a variety of packs, for rather affordable prices. We recommend you check out some of the stores and see which offers are the best for your needs.
  • CovCare – here you can buy certified and FDA approved disposable surgical masks in packs of 50, 100, 250, 500 masks, as well as amounts of over 20 to 500 boxes of masks. There is currently a sale on the site, so make sure to check CovCare out. This is a credible and reliable source of personal protective equipment for the general public as well as the medical staff.
  • LecheeUS – here you can buy packs of registered surgical masks for affordable prices. The masks are FDA approved, and the company ships the masks for free within the US. The masks are also intended for the general public, so by buying these you won’t have to worry about interfering with the supplies for medical workers.

15. What Are The Best Alternatives For Surgical Face Masks?

Some tests have shown that DIY masks can filter a percentage of virus-sized particles.

Sure, these are not as effective as respiratory face masks, but they can still provide protection and reduce hand-to-face contact.

Mask protection level
Image Source: Terry Cralle

You can also purchase N95 or KN95 respiratory face masks, which are currently the best-performing masks when it comes to virus filtration and protection.

Either way, regardless of which other masks you choose, you will do a good job and enable surgical masks to be more available for health care staff.

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Surgical mask – Wikipedia


Mouth and nose cover against bacterial aerosols

Surgical mask
Surgical face mask.jpg

A surgical mask

Other names Procedure mask, medical mask, isolation mask, laser mask, fluid-resistant masks, face mask

A surgical mask, also known as a face mask, is intended to be worn by health professionals during healthcare procedures.[1][2] It is designed to prevent infections in patients and treating personnel by catching bacteria shed in liquid droplets and aerosols from the wearer’s mouth and nose.[3][4][5] They are not designed to protect the wearer from breathing in airborne bacteria or viruses whose particles are smaller. With respect to some infections like influenza they appear as effective as respirators, such as N95 or FFP masks;[6] though the latter provide better protection in laboratory experiments due to their material, shape and tight seal.[7][8]

Surgical masks vary by quality and levels of protection. Despite their name, not all surgical masks are appropriate to be used during surgery. Surgical masks may be labeled as surgical, isolation, dental, or medical procedure masks.[9] Chinese health officials distinguish between medical (non-surgical) and surgical masks.[10]

Surgical masks are made of a nonwoven fabric created using a melt blowing process. They came into use in the 1960s and largely replaced cloth facemasks in developed countries.[citation needed] The use of surgical masks during the COVID-19 pandemic has been a subject of debate,[11] as shortages of surgical masks is a central issue.[12][13]
Surgical masks are popularly worn by the general public all year round in East Asian countries like China, Japan and South Korea to reduce the chance of spreading airborne diseases to others, and to prevent the breathing in of airborne dust particles created by air pollution.[14] Additionally, surgical masks have become a fashion statement, particularly in contemporary East Asian culture bolstered by its popularity in Japanese and Korean pop culture which have a big impact on East Asian youth culture.[15][16]

Health care workers[edit]

A medical professional wearing a surgical mask during an operation

A surgical mask is intended to be worn by health professionals during surgery and certain health care procedures[17] to catch microorganisms shed in liquid droplets and aerosols from the wearer’s mouth and nose.[18]

Evidence supports the effectiveness of surgical masks in reducing the risk of infection among other healthcare workers and in the community.[19] However, a Cochrane review found that there is no clear evidence that disposable face masks worn by members of the surgical team would reduce the risk of wound infections after clean surgical procedures.[20]

For healthcare workers, safety guidelines recommend the wearing of a face-fit tested N95 or FFP3 respirator mask instead of a surgical mask in the vicinity of pandemic-flu patients, to reduce the exposure of the wearer to potentially infectious aerosols and airborne liquid droplets.[21][22][23]

General public[edit]

In community and home settings, the use of facemasks and respirators generally are not recommended, with other measures preferred such as avoiding close contact, maintaining good hand hygiene,[18] and wearing cloth face coverings.[24]

Surgical masks are popularly worn by the general public all year round in East Asian countries like China, Japan, South Korea and Taiwan to reduce the chance of spreading airborne diseases to others, and to prevent the breathing in of airborne dust particles created by air pollution.[14]

In Japan and Taiwan, it is common to see these masks worn during the flu season, as a show of consideration for others and social responsibility.[25][26][27] Surgical masks provide some protection against the spread of diseases, and improvised masks provide about half as much protection.[28]

More recently, due to the rising issue of smog in South and Southeast Asia, surgical masks and air filtering face masks are now frequently used in major cities in India, Nepal and Thailand when air quality deteriorates to toxic levels.[29][30][31] Additionally, face masks are used in Indonesia, Malaysia and Singapore during the Southeast Asian haze season.[32][33] Air filtering surgical-style masks are quite popular across Asia and as a result, many companies have released masks that not only prevent the breathing in of airborne dust particles but are also fashionable.[34][35]

Additionally, surgical masks have become a fashion statement, particularly in contemporary East Asian culture bolstered by its popularity in Japanese and Korean pop culture which have a big impact on East Asian youth culture.[15][16]

Surgical masks may also be worn to conceal identity. In the United States banks, convenience stores, etc. have banned their use as a result of criminals repeatedly doing so. In the 2019–20 Hong Kong protests, some protestors wore surgical masks amongst other types of mask to avoid recognition, and the government tried to ban such use.[36]

Function[edit]

Surgical masks retain some of the respiratory droplets released from the wearer through talking, coughing, or sneezing. Thus they reduce the spread of pathogens.[37]
Shadowgraph videos of the outer airflow during a sneeze, comparing an unmasked sneeze with several different method of covering one‘s mouth and nose[38]

A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splatter that may contain viruses and bacteria, keeping it from reaching the wearer’s mouth and nose.[39] Surgical masks are effective barriers for retaining large droplets released from the mouth and nose by the wearer in public.[37] Surgical masks help reduce exposure of the wearer’s saliva and respiratory secretions to others[39] that could otherwise travel up to 26 feet.[40] Surgical mask also remind wearers not to touch their mouth or nose, which could otherwise transfer viruses and bacteria after having touched a contaminated surface.[38]

A surgical mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the face mask and the face.[39]

A surgical mask is not to be confused with a respirator and is not certified as such. Surgical masks are not designed to protect the wearer from inhaling airborne bacteria or virus particles and are less effective than respirators, which are designed for this purpose.[37] Collection efficiency of surgical mask filters can range from less than 10% to nearly 90% for different manufacturers’ masks when measured using the test parameters for NIOSH certification. However, a study found that even for surgical masks with “good” filters, 80–100% of subjects failed an OSHA-accepted qualitative fit test, and a quantitative test showed 12–25% leakage.[41]

Modern surgical masks are made from paper or other non-woven material and should be discarded after each use.[18]

Physical form[edit]

The design of the surgical masks depends on the mode; usually, the masks are three-ply (three layers). This three-ply material is made up of a melt-blown polymer, most commonly polypropylene, placed between non-woven fabric.[42] The melt-blown material acts as the filter that stops microbes from entering or exiting the mask.[42] Pleats are commonly used to allow the user to expand the mask such that it covers the area from the nose to the chin. The masks are secured to the head with ear loops, head ties, or elastic straps.[43]

Physical properties and quality[edit]

Physical properties of surgical masks
Parameter Typical unit
Pressure differential, ∆P cm of H2O / cm²
Filtration and exposure %
Liquid penetration resistance mbar
Air permeability ml/s⋅cm² at 100 Pa
Water vapor permeability g/24 hr⋅cm²
Water repellency grade

Performance of surgical masks is evaluated based on such parameters as
filtration (mask capture of exhaled aerosols), exposure (transfer of aerosols from outside), mask airflow resistance (pressure difference during breathing, ΔP, also known as breathability),[44] liquid penetration resistance, air and water vapor permeability, water repellency (for outer and inner surfaces).[45]

Filtration and exposure is typically measured in bacterial filtration efficiency (BFE) and particulate filtration efficiency (PFE).[46]

History[edit]

Taiwan instituted a mask rationing system during the COVID-19 pandemic. With population of 24 million, Taiwan has been producing more than 13 million medical masks per day since March 2020.

Modern surgical masks began to be used in the 1960s. Their adoption caused cloth facemasks, which had been used since the late 19th century, to completely fall out of use in the developed world.[47][48] However, cloth masks and surgical masks both continued to be used in developing countries.[49]

COVID-19 pandemic[edit]

During the COVID-19 pandemic, some jurisdictions banned the practice of selling surgical masks to other nations due to a limited supply; however, Taiwan made refinements to those rules by permitting them to be mailed to first and second-degree relatives.[50]

Regulation[edit]

In the United States, surgical masks are cleared for marketing by the U.S. Food and Drug Administration. As of 2009, manufacturers of surgical masks must demonstrate that their product is at least as good as a mask already on the market to obtain “clearance” for marketing. Manufacturers may choose from filter tests using a biological organism aerosol, or an aerosol of 0.1 µm latex spheres.[41]

In the European Economic Area (EEA), surgical masks have to be certified through the CE marking process in order to be commercialized. CE marking of surgical masks involves the respect of many obligations indicated in the Medical Device Regulation (Council Regulation 2017/745 of 5 April 2017 concerning medical devices, OJ No L 117/1 of 2017-05-05).

Surgical masks for use in the US and the EEA conform to ASTM F2100 and EN 14683 respectively. In both standards, a mask must have a Bacterial Filtration Efficiency (BFE) of more than 95%, simulated with particles of size 3.0 μm.[51]

In China, two types of masks are common: surgical masks that conform to YY 0469 standard (BFE ≥ 95%, PFE ≥ 30%, splash resistance) and single-use medical masks that conform to YY/T 0969 standard (BFE ≥ 95%).[46][52] Daily protective masks conforming to GB/T 32610 standard[53] is yet another type of masks that can have similar appearance to surgical masks.

See also[edit]

References[edit]

  1. ^ Smith, Jeffrey D.; MacDougall, Colin C.; Johnstone, Jennie; Copes, Ray A.; Schwartz, Brian; Garber, Gary E. (17 May 2016). “Effectiveness of N95 respirators versus surgical masks in protecting health care workers from acute respiratory infection: a systematic review and meta-analysis”. Canadian Medical Association Journal. 188 (8): 567–574. doi:10.1503/cmaj.150835. ISSN 0820-3946. PMC 4868605. PMID 26952529.
  2. ^ “Advice on the use of masks the community, during home care and in health care settings in the context of the novel coronavirus (2019-nCoV) outbreak” (PDF). www.who.int. Retrieved 2020-02-04.
  3. ^ “Transmission-Based Precautions”. U.S. Centers for Disease Control and Prevention. 2016-01-07. Retrieved 2020-03-31.
  4. ^ “Prevention of hospital-acquired infections” (PDF). World Health Organization (WHO). p. 45. Archived (PDF) from the original on 26 March 2020.
  5. ^ “Clinical Educators Guide: Australian Guidelines for the Prevention and Control of Infection in Healthcare”. Australian National Health and Medical Research Council. December 2019. p. 20. Retrieved 2020-03-30.
  6. ^ Long, Y; Hu, T; Liu, L; Chen, R; Guo, Q; Yang, L; Cheng, Y; Huang, J; Du, L (13 March 2020). “Effectiveness of N95 respirators versus surgical masks against influenza: A systematic review and meta-analysis”. Journal of Evidence-based Medicine. doi:10.1111/jebm.12381. PMC 7228345. PMID 32167245.
  7. ^ “N95 Respirators and Surgical Masks – Blogs – CDC”. CDC Blogs. 2009-10-14. Retrieved 2020-04-29.
  8. ^ Smith, JD; MacDougall, CC; Johnstone, J; Copes, RA; Schwartz, B; Garber, GE (17 May 2016). “Effectiveness of N95 respirators versus surgical masks in protecting health care workers from acute respiratory infection: a systematic review and meta-analysis”. Canadian Medical Association Journal. 188 (8): 567–574. doi:10.1503/cmaj.150835. PMC 4868605. PMID 26952529.
  9. ^ “N95 Respirators and Surgical Masks (Face Masks)”. FDA. Retrieved 12 April 2020.
  10. ^ “For different groups of people: how to choose masks”. NHC.gov.cn. National Health Commission of the People’s Republic of China. 7 February 2020. Archived from the original on 5 April 2020. Retrieved 22 March 2020.
  11. ^ Ting V (4 April 2020). “To mask or not to mask: WHO makes U-turn while US, Singapore abandon pandemic advice and tell citizens to start wearing masks”. South China Morning Post.
  12. ^ “Not Enough Face Masks Are Made In America To Deal With Coronavirus”. NPR.org. 2020-03-05. Retrieved 2020-04-10.
  13. ^ “Chinese mask makers use loopholes to speed up regulatory approval”. Financial Times. 2020-04-01. Retrieved 2020-04-10.
  14. ^ a b Yang, Jeff. “A quick history of why Asians wear surgical masks in public”. Quartz. Retrieved 2020-03-28.
  15. ^ a b Dazed (2015-12-24). “How surgical masks became a fashion statement”. Dazed. Retrieved 2020-03-28.
  16. ^ a b How K-Pop Revived Black Sickness Masks In Japan | Kotaku Australia
  17. ^ Procedure mask. nursingcenter.com
  18. ^ a b c “Interim Recommendations for Facemask and Respirator Use to Reduce Novel Influenza A (H1N1) Virus Transmission”. Centers for Disease Control and Prevention. May 27, 2009. Unless otherwise specified, the term “facemasks” refers to disposable facemasks cleared by the U.S. Food and Drug Administration (FDA) for use as medical devices. This includes facemasks labeled as surgical, dental, medical procedure, isolation, or laser masksFacemasks should be used once and then thrown away in the trash.
  19. ^ MacIntyre, CR; Chughtai, AA (9 April 2015). “Facemasks for the prevention of infection in healthcare and community settings”. BMJ (Clinical Research Ed.). 350: h694. doi:10.1136/bmj.h694. PMID 25858901.
  20. ^ Vincent, Marina; Edwards, Peggy (26 April 2016). “Disposable surgical face masks for preventing surgical wound infection in clean surgery” (PDF). Cochrane Database of Systematic Reviews. 4: CD002929. doi:10.1002/14651858.cd002929.pub3. PMC 7138271. PMID 27115326.
  21. ^ “Interim guidance on planning for the use of surgical masks and respirators in health care settings during an influenza pandemic” (PDF). U.S. Department of Health & Human Services. October 2006. Archived from the original (PDF) on 2016-03-04.
  22. ^ “Working with highly pathogenic avian influenza virus”. UK Health and Safety Executive. Retrieved August 2, 2014.
  23. ^ “N95 Factsheet”. Centers for Disease Control and Prevention. Archived from the original on November 11, 2009.
  24. ^ CDC (2020-02-11). “Coronavirus Disease 2019 (COVID-19)”. Centers for Disease Control and Prevention. Retrieved 2020-07-05.
  25. ^ Juliet Hindell (May 30, 1999). “Japan’s war on germs and smells”. BBC Online.
  26. ^ Negrin, Matt (2009-04-26). “For allergy and flu season, the Japanese turn to surgical masks”. Winnipeg Free Press. Retrieved 2017-09-29.
  27. ^ “CJCU Student Handbook” (PDF). 2016. Retrieved 4 April 2020. In Taiwan, it is considered courteous to wear a face mask if you have a cold and cough and plan to be in close proximity with others
  28. ^ Davies, Anna; Thompson, Katy-Anne; Giri, Karthika; Kafatos, George; Walker, Jimmy; Bennett, Allan (August 2013). “Testing the Efficacy of Homemade Masks: Would They Protect in an Influenza Pandemic?”. Disaster Medicine and Public Health Preparedness. 7 (4): 413–418. doi:10.1017/dmp.2013.43. ISSN 1935-7893. PMC 7108646. PMID 24229526.
  29. ^ “Why are face masks selling out in Bangkok?”. BBC News. Retrieved 2020-03-28.
  30. ^ Punit, Maria Thomas, Itika Sharma. “Delhi’s rich and beautiful are breathing clean air stylishly, with help from the Nevada desert”. Quartz India. Retrieved 2020-03-28.
  31. ^ “Keeping Kathmandu Out”. kathmandupost.com. Retrieved 2020-03-28.
  32. ^ “How to choose the right mask to protect yourself from the haze”. AsiaOne. Retrieved 2020-03-28.
  33. ^ Holliday, Katie (2013-06-20). “Face Masks, Anyone? Singapore Struggles With Haze”. www.cnbc.com. Retrieved 2020-03-28.
  34. ^ Delhi residents brave the smog in style
  35. ^ Hongkongers could benefit from new air pollution mask that’s six times more effective than rivals
  36. ^ Hong Kong protesters defy face mask ban — with humor | News | DW | 18.10.2019
  37. ^ a b c “Respiratory Protection Against Airborne Infectious Agents for Health Care Workers: Do surgical masks protect workers?” (OSH Answers Fact Sheets). Canadian Centre for Occupational Health and Safety. 2017-02-28. Retrieved 2017-02-28.
  38. ^ a b Tang, Julian W.; Nicolle, Andre D. G.; Pantelic, Jovan; Jiang, Mingxiu; Sekhr, Chandra; Cheong, David K. W.; Tham, Kwok Wai (2011-06-22). “Qualitative Real-Time Schlieren and Shadowgraph Imaging of Human Exhaled Airflows: An Aid to Aerosol Infection Control”. PLOS ONE. 6 (6): e21392. Bibcode:2011PLoSO…621392T. doi:10.1371/journal.pone.0021392. ISSN 1932-6203. PMC 3120871. PMID 21731730.
  39. ^ a b c “N95 Respirators and Surgical Masks (Face Masks)”. U.S. Food and Drug Administration. 2020-03-11. Retrieved 2020-03-28.This article incorporates text from this source, which is in the public domain.
  40. ^ Padilla, Ramon; Zarracina, Javier (2020-04-03). “Coronavirus might spread much farther than 6 feet in the air. CDC says wear a mask in public”. USATODAY.com. Retrieved 2020-04-04.
  41. ^ a b Brosseau, Lisa; Ann, Roland Berry (2009-10-14). “N95 Respirators and Surgical Masks”. NIOSH Science Blog. Retrieved 2020-03-28.This article incorporates text from this source, which is in the public domain.
  42. ^ a b “How Surgical Masks are Made, Tested and Used”. ThomasNet. Retrieved 2020-04-05.
  43. ^ Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. The National Academies Press. 2006-03-17. doi:10.17226/11637. ISBN 978-0-309-10182-0. Retrieved 2020-04-05.
  44. ^ Skaria, S.; Smaldone, G. (2014). “Respiratory Source Control Using Surgical Masks With Nanofiber Media”. Annals of Occupational Hygiene. 6 (58): 771–781.
  45. ^ Wong, Chung; Guo, Hu; Guan, Yao; Song, Newton; Newton, E. (2006). “In Vivo Protective Performance of N95 Respirator and Surgical Facemask”. American Journal of Industrial Medicine. 12 (49): 1056–10065. doi:10.1002/ajim.20395. PMID 17096360.
  46. ^ a b 中华人民共和国医药行业标准:YY 0469–2011 医用外科口罩(Surgical mask) (in Chinese)
  47. ^ Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. Washington, D.C.: National Academies Press. 2006-07-24. pp. 6, 36–38. doi:10.17226/11637. ISBN 978-0-309-10182-0.
  48. ^ Chughtai, Abrar Ahmad; Seale, Holly; MacIntyre, Chandini Raina (2013-06-19). “Use of cloth masks in the practice of infection control – evidence and policy gaps”. International Journal of Infection Control. 9 (3). doi:10.3396/IJIC.v9i3.020.13. ISSN 1996-9783.
  49. ^ MacIntyre, C. R.; Chughtai, A. A. (2015-04-09). “Facemasks for the prevention of infection in healthcare and community settings” (PDF). BMJ. 350 (apr09 1): h694. doi:10.1136/bmj.h694. ISSN 1756-1833. PMID 25858901.
  50. ^ News, Taiwan. “Taiwan citizens allowed to mail masks to over…” Taiwan News. Retrieved 8 May 2020.
  51. ^ Robertson, Paddy (15 March 2020). “Comparison of Mask Standards, Ratings, and Filtration Effectiveness”. Smart Air Filters.
  52. ^ 中华人民共和国医药行业标准:YY/T 0969–2013 一次性使用医用口罩(Single-use medical face mask) (in Chinese)
  53. ^ GB/T 32610–2016 Technical specification of daily protective mask

External links[edit]



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N95 Masks vs. Surgical Masks vs. Cloth Masks


Il n’y a pas si longtemps, les respirateurs et les masques chirurgicaux étaient portés presque exclusivement par les travailleurs dont le travail les exigeait. Mais pendant la pandémie de COVID-19, de nombreux types de protections faciales sont devenues de plus en plus courantes dans les lieux publics. Leur visibilité soulève une question évidente: quelle est la différence entre les masques N95 vs masques chirurgicaux vs respirateurs vs masques anti-poussière vs masques en tissu? Quel type de protection offrent-ils?

Masques en tissu

Les Centers for Disease Control and Prevention (CDC) ont recommandé que les personnes porter des revêtements faciaux en tissu en public pour aider à prévenir la propagation du COVID-19, indépendamment du fait qu’ils aient de la fièvre ou d’autres symptômes du COVID-19. Il existe des preuves que le COVID-19 peut être transmis par des personnes qui ne présentent pas de symptômes. Le port de masques en tissu aide à ralentir la propagation du virus, qui se transmet principalement d’une personne à l’autre par les gouttelettes respiratoires produites lorsque nous parlons, toussons ou éternuons. Le CDC recommande des revêtements faciaux en tissu dans les magasins et autres endroits où distanciation sociale est difficile à maintenir, en particulier dans les zones où la transmission communautaire est importante.

  • Bien que les masques en tissu puissent aider à prévenir la propagation du COVID-19 et d’autres maladies, ils ne sont pas considérés comme des équipements de protection individuelle (EPI).
  • Les masques en tissu sont destinés à être nettoyés et réutilisés, contrairement aux masques chirurgicaux et aux respirateurs jetables N95.
  • Les masques en tissu sont faciles à obtenir et simples à fabriquer à la maison. D’autre part, les masques chirurgicaux et les respirateurs N95 ne peuvent pas être fabriqués à la maison et devraient être considérés comme des fournitures essentielles, selon le CDC.

Masques chirurgicaux

Les masques chirurgicaux (également appelés masques médicaux) sont des revêtements amples et jetables pour le nez et la bouche. Ils sont destinés à être portés par les agents de santé. Ils résistent aux fluides et protègent le porteur contre les grosses gouttelettes, les éclaboussures et les sprays, D’après le CDC. Ils captent également les gouttelettes respiratoires du porteur, aidant à protéger les patients contre la contamination.

  • Les masques chirurgicaux ne sont pas considérés comme une protection respiratoire. Selon le CDC, ils n’offrent pas une protection fiable contre l’inhalation de plus petites particules en suspension dans l’air.
  • Les masques chirurgicaux sont autorisés pour une utilisation en milieu médical par la Food and Drug Administration (FDA), qui évalue les données et les allégations fournies par le fabricant du masque.
  • Les masques chirurgicaux sont testés selon les normes publiées par ASTM International comme ASTM F2100-19. Ces normes décrivent l’efficacité de la filtration bactérienne, l’efficacité de la filtration des particules submicroniques, la pression différentielle, la résistance au sang synthétique et l’inflammabilité. Les masques médicaux se divisent en trois niveaux de protection barrière, qui sont décrits ci-après par société de services de santé Cardinal Health:
    • Niveau 1: protection barrière basse
    • Niveau 2: protection barrière modérée
    • Niveau 3: protection maximale de la barrière

Respirateurs N95

Les respirateurs N95 sont généralement jetables et sont communément appelés respirateurs à masque filtrant. OSHA définit un respirateur à masque filtrant comme “un respirateur à particules à pression négative avec un filtre faisant partie intégrante de la pièce faciale ou avec la pièce faciale entière composée du milieu filtrant”.

  • Les masques filtrants N95 offrent une meilleure protection contre les particules en suspension que les masques chirurgicaux ou les masques en tissu, car ils sont conçus pour être bien ajustés et peuvent filtrer les grandes et petites particules, y compris les aérosols.
  • Les masques N95 sont testés et certifiés par le National Institute of Occupational Safety and Health (NIOSH) pour garantir que le masque filtrant peut éliminer au moins 95% des particules en suspension dans l’air.
  • N95 sont conçus pour être bien ajustés. Normalement, les utilisateurs doivent réussir un test d’ajustement pour confirmer une bonne étanchéité avant d’en utiliser un. En raison des préoccupations concernant une pénurie de kits de test d’ajustement et de solutions de test, l’OSHA encourage les employeurs à donner la priorité aux tests d’ajustement pour ceux qui doivent utiliser des respirateurs N95 dans des procédures à haut risque pendant la pandémie de COVID-19.
  • Certains fabricants proposent des respirateurs chirurgicaux à masque filtrant N95, qui sont approuvés par la FDA pour la résistance aux fluides et également testés et certifiés par NIOSH comme respirateur.
  • Les respirateurs N95 ne doivent pas être portés par le grand public comme protection contre le COVID-19 selon le CDC, pour aider à optimiser l’approvisionnement pour les respirateurs les plus humains.

Respirateurs élastomères: une alternative N95

Les respirateurs élastomères réutilisables, plus couramment observés dans les environnements industriels, peuvent fournir une protection similaire aux respirateurs jetables N95, selon le CDC, qui propose conseils sur les respirateurs élastomères pour les professionnels de la santé. Les respirateurs élastomères peuvent avoir un demi-masque ou un masque complet, et ils utilisent des filtres remplaçables pour éliminer les particules de l’air. Ils nécessitent également un nettoyage, une désinfection et d’autres travaux d’entretien. Contrairement aux masques chirurgicaux, les respirateurs élastomères ne sont pas approuvés par la FDA pour la résistance aux fluides.

Masques anti-poussière et autres revêtements faciaux jetables

L’expression «masque anti-poussière» est utilisée par certaines personnes pour décrire tout masque facial jetable, y compris les respirateurs N95. Mais les masques antipoussières ne sont pas nécessairement les mêmes que les respirateurs et sont souvent conçus pour protéger le porteur uniquement des irritants non toxiques, comme la sciure ou le pollen. Ces «masques antipoussières nuisibles» ne sont ni testés ni certifiés par NIOSH pour offrir un quelconque niveau de filtration respiratoire. Les directives du CDC ne traitent pas des masques antipoussières nuisibles, et il n’y a aucune raison de croire qu’un masque antipoussière non certifié NIOSH offrirait une protection respiratoire supérieure à celle d’un masque en tissu.

De même, il existe des revêtements faciaux jetables qui ressemblent à des masques chirurgicaux ou à des masques médicaux, mais qui ne sont pas testés pour la protection de la barrière selon les normes ASTM et ne sont pas autorisés à être utilisés dans les milieux médicaux par la FDA.

Conseils pour porter des masques en tissu

Ces conseils pour le port de masques en tissu sont basés sur les informations du CDC et de la Mayo Clinic:

  • Ne touchez pas votre masque lorsque vous le portez. Si vous le touchez, lavez ou désinfectez vos mains.
  • Lorsque vous retirez votre masque, ne touchez pas votre visage, en particulier votre nez, vos yeux et votre bouche, ni l’avant du masque.
  • Après avoir retiré votre masque, lavez-vous les mains immédiatement.
  • Nettoyez régulièrement votre masque dans une machine à laver.
  • Fabriquez ou recherchez des masques en tissu qui ont plus d’une couche de tissu.
  • Assurez-vous que les masques en tissu couvrent le nez et la bouche et sont fixés avec des attaches ou des boucles d’oreille, bien ajustés mais confortablement.
  • N’oubliez pas que si le port d’un masque en tissu est une précaution importante contre la propagation du COVID-19, il est toujours important de se laver les mains fréquemment et de suivre les directives de distanciation sociale.
  • N’oubliez pas que les masques en tissu ne remplacent pas la protection respiratoire requise.



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Face Masks and Surgical Masks for COVID-19: Manufacturing, Purchasing, Importing, and Donating Masks During the Public Health Emergency


masque chirurgical - masques faciaux et masques chirurgicaux pour COVID-19

En général, les masques sont utilisés par le grand public et le personnel de santé pour empêcher la propagation d’une infection ou d’une maladie.

Cette page est destinée aux personnes et aux organisations qui travaillent pour la première fois avec la FDA. Pour aider à élargir la disponibilité des masques faciaux et des masques chirurgicaux, la FDA offre une flexibilité réglementaire, comme décrit dans notre politique pour les masques faciaux et les masques chirurgicaux qui est en vigueur pendant la pandémie COVID-19.

Si vous êtes intéressé par la fabrication de ces produits, nous vous exhortons à consulter l’autorisation d’utilisation d’urgence (EUA) de la FDA pour masques faciaux (PDF-98KB) (publié le 24 avril 2020) et la politique de la FDA sur masques faciaux et masques chirurgicaux en vigueur pendant l’urgence de santé publique COVID-19, et lisez les informations sur cette page. Vous pouvez envoyer des questions spécifiques à CDRH-COVID19-SurgicalMasks@fda.hhs.gov.

Q: Quels masques sont les appareils médicaux réglementés par la FDA?

A. Les masques faciaux commercialisés auprès du grand public à des fins générales non médicales, telles que l’utilisation dans la construction et d’autres applications industrielles, ne sont pas des dispositifs médicaux. Les masques faciaux, lorsqu’ils sont destinés à un usage médical tel que le contrôle à la source (y compris les utilisations liées au COVID-19) et les masques chirurgicaux sont des dispositifs médicaux.

Q: Y a-t-il une différence entre un masque et un respirateur?

UNE: Masques et respirateurs les deux couvrent le nez et la bouche du porteur, mais ils diffèrent sur plusieurs aspects.

Les masques sont amples et peuvent ne pas offrir une protection complète contre l’inhalation d’agents pathogènes en suspension dans l’air, tels que les virus.

  • Masques faciaux (masques non chirurgicaux) peut ne pas fournir de protection contre les fluides ou ne pas filtrer les particules, nécessaires pour se protéger contre les agents pathogènes, tels que les virus. Ils ne sont pas destinés à un usage chirurgical et ne sont pas considérés comme des équipements de protection individuelle.
  • Masques chirurgicaux sont des dispositifs résistants aux fluides, jetables et amples qui créent une barrière physique entre la bouche et le nez du porteur et l’environnement immédiat. Ils sont destinés à être utilisés en milieu chirurgical et ne fournissent pas une protection complète contre l’inhalation d’agents pathogènes en suspension dans l’air, tels que les virus.

Les respirateurs sont des équipements de protection individuelle qui s’adaptent étroitement au visage et filtrent les particules en suspension pour protéger les travailleurs de la santé. Ils offrent un niveau de protection plus élevé contre les virus et les bactéries lorsque correctement ajusté. Ce document ne traite pas des respirateurs.

Ce Infographie CDC explique les différences entre les masques chirurgicaux et les respirateurs N95.

Q: Je suis intéressé par la fabrication de masques faciaux pour COVID-19. Qu’est-ce que je dois faire?

R: Cela dépendra du type de masque que vous souhaitez fabriquer.

Les masques à usage non médical ne sont pas des dispositifs médicaux et ne sont pas réglementés par la FDA.

La FDA a publié un EUA pour les masques faciaux qui répondent à certains critères, y compris les revêtements faciaux en tissu recommandés par les Centers for Disease Control (CDC). Pendant l’urgence de santé publique COVID-19, un masque facial à usage médical qui est destiné à être utilisé comme contrôle à la source, n’est pas étiqueté comme masque chirurgical et n’est pas destiné à fournir une protection contre les liquides, peut être autorisé en vertu de la “parapluie” EUA pour les masques faciaux sans soumettre de documentation à la FDA si le masque facial répond aux critères d’éligibilité. Un masque facial autorisé en vertu de cet EUA doit être conforme aux conditions d’autorisation (section IV) de l’EUA. Veuillez noter que cet EUA n’autorise pas l’utilisation des masques faciaux comme équipement de protection individuelle.

En plus de l’EUA «parapluie» pour les masques faciaux, comme décrit dans la politique de la FDA sur masques faciaux et masques chirurgicaux en vigueur pendant l’urgence de santé publique COVID-19, la FDA ne s’attend pas à ce que les fabricants de masques faciaux à usage médical qui ne sont pas destinés à fournir une protection contre les liquides présentent une notification à la FDA avant de commencer à commercialiser leur produit, ou à se conformer à certaines exigences réglementaires, lorsque le masque facial ne le fait pas. créer un risque indu à la lumière de l’urgence de santé publique.

En vertu de cette politique, la FDA estime que les masques faciaux non destinés à fournir une protection contre les liquides ne créent pas un tel risque indu lorsque:

  • Les masques faciaux incluent un étiquetage qui:
    • Décrit avec précision le produit comme un masque facial (par opposition à un masque chirurgical ou à un respirateur à masque filtrant);
    • Comprend une liste de matériaux en contact avec le corps (qui n’inclut aucun médicament ou produit biologique); et
    • Comprend des recommandations et des déclarations générales qui réduiraient le risque d’utilisation. Par exemple, des recommandations contre l’utilisation:
      • Dans tout cadre chirurgical ou dans les cas où une exposition significative à des liquides, corporels ou autres liquides dangereux peut être attendue;
      • Dans un environnement clinique où le niveau de risque d’infection par inhalation est élevé;
      • En présence d’une source de chaleur à haute intensité ou d’un gaz inflammable;
  • Les masques faciaux ne sont pas destinés à un usage qui créerait un tel risque indu. Par exemple, l’étiquetage n’inclut pas les utilisations pour la protection antimicrobienne ou antivirale, la prévention ou la réduction des infections ou les utilisations connexes, et n’inclut pas les allégations de filtration des particules.

Q: Je suis intéressé par la fabrication de masques chirurgicaux pour COVID-19. Qu’est-ce que je dois faire?

Lors de l’urgence de santé publique COVID-19, et comme décrit dans la politique de la FDA sur les masques faciaux et les masques chirurgicaux qui est en vigueur pendant l’urgence de santé publique COVID-19, la FDA ne s’attend pas à ce que les fabricants de masques chirurgicaux destinés à fournir une protection contre les liquides de soumettre une notification à la FDA avant de commencer la commercialisation de leur produit, ou de se conformer à certaines exigences réglementaires lorsque les masques chirurgicaux ne créent pas de risque indu à la lumière de l’urgence de santé publique.

En vertu de la politique, la FDA estime que les masques chirurgicaux destinés à fournir une protection contre les liquides ne créent pas de risque indu lorsque:

  • Les masques chirurgicaux répondent à des performances de barrière aux liquides conformes à Norme ASTM F1862 et l’exigence d’inflammabilité de classe I ou de classe II selon 16 CFR partie 1610 (sauf si étiqueté avec une recommandation contre l’utilisation en présence d’une source de chaleur de haute intensité ou d’un gaz inflammable);
  • Les masques chirurgicaux comprennent un étiquetage qui décrit avec précision le produit comme un masque chirurgical et comprend une liste des matériaux en contact avec le corps (qui ne comprennent aucun médicament ou produit biologique); et
  • Les masques chirurgicaux ne sont pas destinés à un usage qui créerait un tel risque indu. Par exemple, l’étiquetage n’inclut pas les utilisations pour la protection antimicrobienne ou antivirale, la prévention ou la réduction des infections ou les utilisations connexes, et n’inclut pas les allégations de filtration des particules.

Q: Je souhaite importer des masques pour COVID-19. Qu’est-ce que je dois faire?

R: Pour éviter les retards d’envois légitimes, nous exhortons les importateurs à examiner Importation de fournitures pour COVID-19 et instructions aux importateurs pour des informations importantes sur l’importation de produits, y compris les masques faciaux et les masques chirurgicaux, afin de garantir que la documentation appropriée est soumise au moment de l’entrée. La FDA est prête et disponible pour s’engager avec les importateurs afin de minimiser les perturbations pendant le processus d’importation. Si vous avez des questions concernant le processus d’importation général, vous pouvez envoyer un e-mail COVID19FDAIMPORTINQUIRIES@fda.hhs.gov. Si vous avez des questions concernant une entrée active, veuillez contacter le bureau de la FDA couvrant votre port d’entrée en visitant le Page Bureaux d’importation et port d’entrée de la FDA.

Q: Je souhaite acheter des masques pour COVID-19. Comment savoir s’ils sont contrefaits ou frauduleux?

R: La FDA ne délivre aucun type de certification pour démontrer qu’un fabricant est en conformité avec les exigences de la FDA.

La FDA n’a pas de liste exhaustive de tous les produits contrefaits ou frauduleux. Pour signaler les produits COVID-19 frauduleux à la FDA, veuillez envoyer un e-mail FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.

Q: Je voudrais acheter des masques pour les travailleurs de la santé pendant la pandémie COVID-19. Comment puis-je les obtenir?

R: La FDA n’a pas de liste de fournisseurs de masques. Si vous êtes un établissement de santé, consultez votre fournisseur, distributeur ou votre service de santé local.

Q: J’aimerais faire don de masques aux travailleurs de la santé pendant la pandémie COVID-19. Comment pouvez-vous m’aider avec mon don?

R: La FDA n’achète ni ne distribue de masques. Si vous souhaitez faire un don de masques, veuillez consulter COVID-19 Offre de fournitures ou d’équipements médicaux.

Q: Je voudrais réutiliser les masques pendant la pandémie COVID-19. Qu’est-ce que je dois faire?

R: En cette période de forte demande de masques, il y a stratégie de conservation pour atténuer les pénuries de masques.

Q: Un masque peut-il prétendre être conforme à une norme d’efficacité de filtration du National Institute for Occupational Safety and Health (NIOSH)?

R: Non. Les masques ne peuvent prétendre répondre à une norme d’efficacité de filtration NIOSH. De telles allégations ne peuvent être faites que pour un respirateur, lorsque le respirateur atteint une efficacité de filtration spécifiée.

Prochaines étapes

Si vous êtes toujours intéressé par la fabrication de masques faciaux et / ou de masques chirurgicaux à utiliser pendant la pandémie COVID-19, consultez ces documents:

Documents de la FDA

Autres documents



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