Counterfeit N95 Masks - How Do You Know?
Over the last year, you may have heard that millions of counterfeit N95 masks were found by the Department of Homeland Security. Recently, a seizure of 1.7 million masks found in a Queens, NY storehouse made news across the country. As it turns out, the nation has been deluged with counterfeit N95 masks.
OSHA has been targeting healthcare facilities recently and several in the northeast have been issued citations under the respiratory protection standard CFR1910.134 related to their use of N95 masks. The citations were issued for lack of a Respiratory Protection Plan, lack of respiratory fit testing, and also included active use of counterfeit masks and counterfeits found in their storage rooms.
The Department of Homeland Security is finding the counterfeits in customs and OSHA is finding them in healthcare facilities. These masks are being confiscated; it’s good to know they are off the streets! But what about the ones that weren’t found? You may have experienced getting out a new mask only to find that it felt thin, it didn’t fit quite right, or smelled funny. How do you KNOW a fake? Those who have been fitted and trained using real N95 masks may know when they find a mask “that’s not quite right.” Caregivers outside the hospital may not have had to use an N95 mask regularly, so they haven’t had a fit test and the associated respirator training.
The N95 mask should have certain markings on the box and on the mask. These markings demonstrate that the respirator was manufactured according to NIOSH standards– The National Institute for Occupational Safety and Health. The CDC published an updated note (updated April 13, 2021) on how to identify NIOSH-approved respirators. Here is a diagram of the mask markings that should appear on a NIOSH approved filtering facepiece respirator:
- the mask does not have NIOSH markings.
- there are straps that go around the ears.
- there is no manufacturing lot number or TC approval number.
- the box labeling gives approval for use on children.
- there are decorations, sequins, flowers, etc… on the mask.
- the brand, model, and size you were fit tested for does not fit and provide a seal as before.
- there is a chemical smell or foul odor – such as gasoline, urine, or formaldehyde.
- the printing on the N95 is crooked or off center.
- NIOSH is spelled wrong on the mask or on the box.
- the mask markings smears with an alcohol wipe.
- there is no identifying information on the mask.
- the box lot number does not match the mask lot number.
- the box is missing information like the lot number, bar code or manufacturing location.
- the mask is small and thin, and the filter material looks like a paper towel.
- the straps are stapled onto the mask irregularly.
- 3M specific: if the box has a round MYLAR seal on it with printing marked PERU.
The NIOSH approval number and approval label are your keys to identifying NIOSH-approved respirators. Respirator approvals are occasionally revoked. If this should happen, NIOSH sends a User Notice to all NIOSH NPPTL listserv subscribers and removes the approval number from NIOSH listing. However, inventories of the revoked respirators may still be available for purchase or consumers may have them on hand from an earlier purchase. You may verify that respirator approvals are valid by checking the information links on the NIOSH Trusted-Source page, or in the NIOSH Certified Equipment List (CEL). Users are encouraged to self-subscribe to the NIOSH listserv service to receive User Notice email notifications concerning the status of respirator approvals and other relevant information.
Both an approval label and user instructions are supplied with all NIOSH-approved respirators. These documents should not be discarded before all of the respirators are used or discarded. In addition to the approval number, the NIOSH approval label contains contact information for the respirator manufacturer/supplier, cautions, limitations for use, and directions for proper use. It is especially important to read and follow all of the manufacturer’s instructions for the particular respirator that you are using.
For Purchasing Agents: The CDC publishes user notices of manufacturers/brands / model numbers that have been found to be counterfeit. Additionally, consider these issues:
- When buying directly from a website look for typos, poor grammar, or other errors on the site like unfinished or blank pages, broken links, or misspelled domains.
- Does the website call the product genuine or real?
- Have reviews been left on the product or on the seller?
- Is the price too good to be true?
- Is the seller selling the products over time – or changing products depending on the trends?
- Does the seller put their contact information in the images?
The CDC regularly updates the NIOSH APPROVED N95 particulate filtering facepiece respirator listing as more manufacturers, brands, and models are approved. That listing is alphabetical and also includes links to the manufacturers’ supporting documentation and instructions.