December 8, 2020 By danny.carvalho@ymail.com Off

N95 vs. KN95 vs P95/P100 Masks

With the array of masks on the market, it can be challenging to discern the differences and to figure out which are best suited to your needs. To help you make an informed decision in your sourcing, we’ve compiled this guide on N95, KN95, P95, and other similar respirator masks, including their types, differences, and how to use them. If you’re more interested in sourcing for these types of masks, you can also check out our guide to the top suppliers of respirators and surgical masks.

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. 

Over the course of this guide, we’ll be covering:

  1. What are N95 Masks?
  2. What are KN95 Masks?
  3. What are P95 and P100 Masks?
  4. Comparing N95, KN95, and P95 Masks
  5. Similar Approved Masks from Other Countries
  6. Guidelines for Usage

What are N95 masks?

N95 masks are a specialty type of filtering mask known as a respirator regulated by the U.S. Centers for Disease Control (CDC) and NIOSH (the National Institute for Occupational Safety and Health, part of the CDC). More specifically, they’re class II devices regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84. N95s are made of special nonwoven fabrics which can filter out 95% of particles above .3 microns in size (hence the name). As a mask type that provides some of the most protection against COVID-19, these products have been in short supply since the beginning of the pandemic. We cover what N95 masks are and how they’re constructed in more detail in our guide on how N95 masks are made.

Not all N95 masks are made for surgical applications, although the government has approved the use of industrial N95s in light of recent mask shortages. Surgical N95s are tested with simulated blood to ensure they are fluid resistant, while industrial N95s are not. Surgical N95s are also tested to ensure they filter particles expelled by the wearer, while the industrial kind is only tested for filtration of particles coming from the outside. Since they are meant for industrial environments, however, industrial N95s are more heavily tested on their particle filtration abilities.

NIOSH recommends that once NIOSH-approved filtering facepiece respirators such as N95s have run out, workers use reusable elastomeric respirators or powered air-purifying respirators (PAPRs). However, under current circumstances those options are not always available. This is why the FDA, which approves N95s, has allowed the use of non-NIOSH approved N95 equivalents from other countries.

What are KN95 masks?

KN95 masks are the Chinese equivalent of an N95 mask, vetted through the Chinese certification system. However, it’s essential to use caution when purchasing these masks. Starting April 3rd, after allowing the use of masks tested under similar standards to N95s in other countries, the FDA allowed for the use of KN95s in medical environments as long as they had been certified by accredited testing bodies. However, recent tests by the CDC have shown that many KN95 masks imported do not meet minimum standards for protection. In response, the FDA has banned the Chinese manufacturers whose products did not meet specification from its approval list and has given them time to retest their products to be reinstated on the list.

This does not mean that all KN95 masks are useless, but it’s important to use caution when purchasing these masks. Many of the masks tested by the CDC and FDA turned out to be counterfeits, while others, though legitimate, still did not meet standards. We cover what to watch out for and how to weed out counterfeit PPE in another article. Still, it’s important to note that counterfeits of other masks including N95s have also come from China, so it’s essential to be careful when buying any type of mask. Looking for the correct markings and getting in contact with the manufacturer to ensure the product is theirs can help you to avoid counterfeits.

There are also still several Chinese manufacturers whose KN95s exceeded the standards for the CDC’s tests. The FDA has posted an updated list of Chinese KN95 manufacturers that passed quality assurance tests on its website, as well as a list of the manufacturers that didn’t. The FDA has also approved respirators with 95% filtering ability from Europe, Korea, and Mexico for use in the United States, which are outlined in more detail below.

What are P95 and P100 Masks?

P95 and R95 masks are part of the same family as N95s. They are also certified by NIOSH. While a P95 can also filter out 95% of small particles, it has the additional ability to strongly protect the wearer from oil particles. R95s rest in between, with light oil resistance (which translates to fewer hours before they must be discarded). In the same way an N95 filters out 95% of small particles, an N99, R99, or P99 filters out 99% of small particles, and an N100, R100, or P100 filters out 99.97%. This makes any of these masks a safe alternative to an industrial N-rated mask.

Comparing N95, KN95, and P95 Masks

N95, P95, and FDA approved KN95 masks are virtually identical when it comes to protection from diseases such as coronavirus. All three types of masks are certified to filter out 95% of small particles and fit tightly to the face. However, there are some minor differences in terms of fit and price.

  • N95 masks feature elastic straps that go around the user’s head. This creates a tighter seal than given by KN95s, but it also can feel more uncomfortable for some users.
  • KN95 masks are generally cheaper than N95s, and feature ear loops instead of straps. This makes them easier to put on and take off, but it also can also mean a slightly looser fit.
  • P95s (and R95s) are the most expensive of the three mask types because of their enhanced oil resistance. They also feature elastic head straps to give a tighter seal.

Similar Approved Masks from Other Countries and Europe

On March 28th, the FDA allowed for masks tested to similar standards from other countries and Europe to be certified with an Emergency Use Authorization, as long as the manufacturer or importer follows specific requirements to be certified. These masks include:

  • P2 and P3 masks tested by AS/NZS 1716:2012 performance standards according to AS/NZS 1715:2009 guidance (from Australia)
  • PFF2 and PFF3 masks tested by ABNT/NBR 13698:2011 standards according to Fundacentro CDU 614.894 guidance (from Brazil)
  • FFP2 and FFP3 masks tested by EN 149-2001 standards according to EN 529:2005 guidance (from Europe).
  • DS/DL2 and DS/DL3 masks tested by JMHLW-2000 standards according to JIS T8150:2006 guidance (from Japan)
  • Special 1st masks tested by KMOEL-2017-64 standards according to KOSHA GUIDE H-82-2015 guidance (from Korea)
  • P95, P99, P100, R95, R99, R100, P95, P99, and P100 masks tested by NOM-116-2009 standards according to NOM 116 guidance (from Mexico)
  • Respirators with the European CE mark, an ARTG (Australian Register of Therapeutic Goods) Certificate of Inclusion, a Health Canada License, a Japan Pharmaceuticals and Medical Device, or a Ministry of Health Labor and Welfare approval are also acceptable.

The FDA has also released a list of approved respirators from other countries. 

Guidelines for Using N95-Type Masks

Because of mask shortages and the nature of healthcare work, healthcare workers and first responders should be given first priority for these types of respirators. The FDA and CDC do not recommend these masks for the general public, who should wear cloth masks and stay 6 feet away from others while outside. N95s are also not designed for children or people with facial hair, as the hair will keep the mask from sealing correctly around the face, and N95s are not made to fit children’s smaller faces. N95s can make it more difficult to breathe, so people who have difficulty breathing (such as asthmatics) should consult a doctor before wearing them.

N95s are designed to fit tightly to the face to create a seal, which is why they come in different sizes. Users must train on how to fit masks to their faces properly, and get fit tested once a year to ensure they are still using the right mask. Not all models of masks will fit the same, so in ideal conditions, users would try multiple models to find one with a proper fit.

When wearing an N95, always follow the manufacturer’s instructions. Masks should cover both the nose and mouth and form a seal around them to keep matter from getting in. Additionally, both straps should be used to keep the mask in place. It’s important to avoid touching the outside of the mask once it’s on, too, as the user can contaminate themselves with any viruses on the outside of the mask.

To ensure a mask fits properly, you’ll need to check the seal through both positive and negative pressure checks. To perform either check, the wearer must put both hands over the mask without moving it and cover the exhalation valve if there is one. For a negative pressure check, the user should inhale sharply. If the mask pulls into the face without leaking air, it passes the test. If it leaks around the eyes or face, the wearer should try readjusting the straps and nosepiece. For positive pressure checks, the user should breathe out sharply. Again, air should not leak out, otherwise the mask should be readjusted.

Since N95s are meant to be disposable, they should be disposed of once they are no longer useable. N95s work by trapping viruses and particles in a maze of magnetized plastic fibers, so simply washing them will not clean the particles out, and steaming them may melt the fibers and destroy the mask’s ability to filter. They should be discarded (with the hands washed before and afterward to avoid self-contamination) once the mask becomes dirty, deformed, or damaged. However, when there are no other options it may be necessary to reuse or clean masks, which we have covered in another article. The CDC has also released detailed recommendations on extending the use of respirators.

Conclusion

While there are multiple types of N95-style masks to choose from that provide the same level of safety, it’s important to remember that no mask will give total protection. Using other PPE, hand washing, and other safety measures must also be implemented to provide the highest level of safety. Additionally, ensuring masks fit and are correctly used will go a long way to ensuring the wearer’s safety.

For more information on related topics, we encourage you to check out our Industrial Guides section on Thomasnet.com. You can also start sourcing for N95 masks now with our COVID-19 Response Page, or sign up for our free matchmaking service for COVID-19 related manufacturing partnership opportunities, and for public sector organizations, donations and supplies.

Sources:

  1. FDA Announcement
  2. New York Times
  3. Accumed
  4. CDC
  5. Occupational Health and Safety
  6. 3M
  7. Major Safety
  8. FDA- Respirators and Surgical Masks
  9. New York State Health Department

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