The N95 vs. KN95 Debate
According to the FDA, an N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles. Note: we use face mask, filtering facepiece respirator (FFR), respirator and mask interchangeably below.
Due to this regulated and controlled testing by the FDA (in the United States), the masks are very effective when fitted correctly and used in medical settings. This high standard and certification process unfortunately means that many manufacturers around the world try to take advantage of the N95 designation by claiming that their products are “certified N95” or similarly, called KN95 respirators, which are known as the Chinese equivalent. But are KN95 masks actually equivalent? The short answer is no.
Why choose only a N95 mask?
If properly fitted, the filtration capabilities of N95 respirators exceed those of other types of face masks. However, even a properly fitted N95 respirator does not completely eliminate the risk of illness or death. For example, N95 respirators are not designed for children or people with facial hair.
Because a proper fit cannot be achieved on children and people with facial hair, the N95 respirator may not provide full protection. For example, doctors and nurses must (in normal times) pass a fit test, and determine which size N95 mask actually fits their face, before they are placed in high-risk settings with patients with a coronavirus, or other infectious disease.
These same tests are not carried out with the KN95 products or other counterfeit N95 masks, as they are not held to the same filtration and sizing standards, and are subject to counterfeiting.
Which N95 masks are cleared for the general public in public health medical emergencies?:
- 3M™ Particulate Respirator 8670F
- 3M™ Particulate Respirator 8612F
- Pasture Tm F550G Respirator
- Pasture Tm A520G Respirator
Other N95 masks are also OHSA and CDC approved and are currently in use. According to 3M, “All certified N95 or higher-rated particulate respirators can filter airborne biological particles such as viruses and bacteria.” A full list of NIOSH certified respirators for all other uses can be found here.
What are the problems with a KN95 mask from China or other countries?
Because the stringent filtration standards are not applied and tested in a controlled certification process environment for KN95 and other masks, their effectiveness is unknown, and the quality varies too widely to be trusted.
How to tell if a N95 mask is counterfeit?
It is important to know if you are receiving a counterfeit N95 face mask, as you may be putting your or other people’s lives in danger if you use it in an infectious disease setting. The CDC keeps a full list of certified manufacturers of N95 respirators, surgical N95 respirators and more, which should always be cross-checked to see if the brand is listed.
Unfortunately, many counterfeit mask makers will also use other brands approval certification numbers as their own. For this reason, the CDC also has an updated website that provides examples of brands that are using certification numbers from other manufacturers and passing them off as their own.
Other companies may put certification numbers that look official and are similar to other approve models, however they are actually NIOSH-approved (The National Institute for Occupational Safety and Health).
Another major thing to look for when trying to find out if your N95 respirator is counterfeit or real, is to look for the standard markings on the outside of the mask, that all follow a consistent pattern. These will include:
- Brand name, registered trademark, or easily identifiable marker
- Approval #TC-XXX-XXXX
- Model # XXXX
- NIOSH name in block letters or a NIOSH logo
- Filter class (N,P, or R) and Filter efficiency level (95, 99, 100, etc.)
- Lot # (recommended but not required)
See the image below for the standard layout of an approved N95 respirator
Markings on a NIOSH-approved respirator may appear on the mask itself or on the straps, but should include all of the info listed above. If it has approval markings on it, but is not on the NIOSH table of approved list, it is likely to be either a counterfeit product or a respirator that has had its certification revoked or rescinded by NIOSH.
If there is no TC number on the respirator’s packaging, the user instructions, or the product itself, it is not NIOSH-approved. If you are unsure of your respirator’s approval status, you can call NIOSH at 412-386-4000.
Do I need to worry about fake N95 masks?
Unfortunately, due to the novel coronavirus situation in early 2020, the ability to potentially make money off of these masks has led to a sharp increase in reports of counterfeit masks and other products. With the US government and most states reporting extreme shortages or complete lack of personal protective gear, the situation towards KN95 masks also seems to be changing.
In a reversal of previous bans on the importation of KN95 masks from China, it now appears that the FDA has relaxed that ban.
Due to the previous ban on imports, many people who were trying to help import and donate masks to their local medical facilities China were finding that shipments were held up in customs and potentially not being delivered at all, as the Chinese KN95 masks were not technically allowed.
Chinese KN95 Masks on the Market
According to Buzzfeed, the FDA has not to date publicly explained the exclusion of KN95 masks from its emergency use authorization during the 2020 COVID-19 pandemic. In fact, the response has been very confusing, with the following seemingly contradictory statements having been made.
- Kn95 masks previously mentioned as a ‘suitable alternative’ to N95 masks in previous FDA communications.
- No official mention by the FDA made at all of the KN95 masks in any public forum regarding the current outbreak.
- FDA deputy commissioner for medical and scientific affairs Anand Shah says in an interview “the FDA is not blocking KN95 mask importations,” but to import then is to take on considerable risk, as the masks have no legal protections or other federal support normally provided to approved N95 masks.
To further muddy the waters, Shah also commented that China does have standards as rigorous as the US, but there are simply too many ‘inauthentic’ products labeled as KN95 coming into the market that the agency has simply decided not to officially certify any of the Chinese KN95 masks.
What should be done about counterfeit N95 masks?
In an ideal world, these masks would NOT be used in any setting, as the certifications process and legal protections offered by NIOSH and the FDA are simply not present for KN95 masks. However, during times of extreme shortages, it is already being reported that many hospitals and medical facilities are accepting donations of them, as they are ultimately better than nothing.
There is concern that hospitals or other facilities may be opening themselves up to legal liability if they put staff or patients at risk due to the use of inadequate or counterfeit masks, as real lives are at risk. There is certainly no clear conclusion in times of an emergency shortage of personal protective equipment (PPE). To determine if the mask you are looking at is a real N95 mask, The NIOSH publication 2013-138 “Respirator Awareness: Your Health May Depend on It” provides additional information to look for when verifying your respirator is truly NIOSH-approved.
The CDC also keeps a continually updated list with pictures on their website of non-certified masks that are circulating or masquerading as official N95 products.
Importing KN95 masks from China
If you have determined that a local organization needs masks and cannot get certified N95 masks due to a shortage, and is willing to accept other masks that do not meet the same standards, be careful when contacting suppliers or resellers directly. Because it is such a hot topic during a pandemic and price gouging is rampant, coupled with a bottleneck in the supply and logistics chain in China, you may encounter many problems.
The American Chamber of Commerce in Shanghai has released a step by step guide to procurement in China of PPE. They state, “U.S. customers need to be aware when importing to the U.S. that several types of medical supplies — for example, KN95 masks — are being stopped or denied entry by U.S. Customs. The burden is on the U.S. customer to confirm the items can be imported. It is important to state clearly what the product will be used for and for the U.S. customer to verify it can be used on their end. We have seen cases where a KN95 mask shipment imported for “Industrial/Civic use” has been allowed in, while the same mask destined for a medical facility has been refused entry by U.S. Customs due to FDA requirements.”
For their full guide, which includes information on step-by-step PPE procurement (finding suppliers, auditing their credentials, get a FOB price quote, 3rd party audits, contract signing, ordering and payment, clearing export customs and clearing import customs, etc.) download the report here.
The website also includes contacts for suppliers and traders in PPE, lawyers, QC, logistics and more.
Expanded emergency authorization for N95-style mask
On March 28, 2020 the FDA increased the scope of ‘authorized’ filtering facepiece respirators (FFRs aka masks), due to the fact that ‘it is reasonable to believe that the authorized respirators may be effective in preventing HCP exposure to pathogenic biological airborne particulates during FFR shortages, and that the known and potential benefits of the authorized respirators, when used to prevent HCP exposure to such particulates during FFR shortages during COVID-19, outweigh the known and potential
risks of such products;
Chinese KN95 masks were not included in this list. However, the following are:
Disposable FFRs which have a marketing authorization in one of the following regulatory jurisdictions:
• European CE Mark
• Australian Register of Therapeutic Goods (ARTG) Certificate of Inclusion
• Health Canada Licence
• Japan Pharmaceuticals and Medical Device (PMDA)/Ministry of Health
Labour and Welfare (MHLW
For the full text of the expanded emergency authorization, click here.