Safety First: Beware of Counterfeit N95 Masks

by Walter Valliere, ScD

Consulting Director

Did you know that more than 11 million N95 masks were seized by the U.S. Department of Homeland Security because they are fraudulent?  As a microbiologist who has worked extensively in biosafety level 3 and 4 laboratories (also known as P3 and P4 laboratories) before embracing a career in scientific and laboratory consulting, I was appalled. After all, personal protection is critical when working with high-risk microorganisms that cause diseases such as tuberculosis, bubonic plague, hemorrhagic fever, and others.

Frontline laboratory and medical workers rely on N95 masks to protect themselves from infectious agents while interacting with clinical specimens and individuals suffering from highly infectious microbial diseases. But individuals are only protected if the N95 masks are worn correctly. The Centers for Medicare & Medicaid Services notes the three key criteria that are required for a mask to be effective: select a mask that can filter particles that pass through it; ensure the mask fits the face snugly, creating a seal (facial hair, such as a beard, will reduce the ability for a snug fit); and ensure that the mask is donned and doffed correctly.

The increasing presence of counterfeit N95 masks on the market presents a substantial danger to laboratorians working in biosafety level 2 and 3 facilities and front-line medical personnel who rely on N95 masks for personal safety in high-risk of infection environments. Here are three ways you can check to determine if a N95 mask is a counterfeit:

1. The markings—The markings on the outside of an N95 mask are key—a blank N95 is a red flag that it is not authentic. Check to make sure that the mask has the "NIOSH" logo or acronym spelled correctly and in block letters, which indicates that it has been approved by National Institute for Occupational Safety and Health.

Next, look for the manufacturer’s name (for example, 3M), a registered trademark or clearly understood abbreviation to be printed in a crisp, legible fashion on the mask. Blurry or smudged printing is another red flag. You also should search the brand name on the Centers for Disease Control and Prevention’s webpage or the NIOSH trusted-source webpage to make sure that it is approved by NIOSH (the display of an unauthorized NIOSH logo is common on counterfeit masks).

Lastly, the mask should have a testing and certification code, which is "TC" followed by a numerical code. Other required numbers include the filter class (a letter: N, P or R) and efficiency (95, 99 or 100), for example, "N95." There should be an alphanumerical model number printed on the mask, and it is recommended that the mask also includes the lot number, but that is not universal.

2. How it attaches to the face—N95 masks are designed with two bands that fit around the back of the head and neck to ensure a snug seal around the nose and mouth. If a mask has ear loops, or ties instead of head bands, then it is a counterfeit N95 mask.
3. Your experience—Review the vendor’s history before purchasing. Remember, if it is too good to be true, do not proceed to purchase without getting a second opinion. In addition, if you see “buzz words” on product packaging such as “genuine” or claims that exceed established standards or recommended practices, consider deferring the purchase. Lastly, check for spelling errors, bad grammar and misaligned printing on product packaging, which could indicate that a product is counterfeit.

If you have a concern about the authenticity of your organization’s N95 mask, contact the manufacturer directly. 3M has information online, which includes a fraud hotline. Additional information is available via Vizient's COVID-19 guide to face masks and filtering facepiece masks. Vizient only contracts with pre-qualified and NIOSH-approved sources for N95 masks. If you are a Vizient member and have any concerns about the manufacturing quality standards, pricing and reputation of any product manufacturer, feel free to reach out to Vizient’s Carla Gremillion.