WHAT IS THE FUTURE OF VALUE-BASED CARE?

Commercial risk will be a critical catalyst of progress – it’s complicated, but is it possible? We think so.

X

January 18, 2022

12 ways to spot a fake N95, KN95, or KF94 mask

Daily Briefing

    As the omicron variant continues to surge, many people are once again struggling to find more protective masks, such as N95s, KN95s, and KF94s—but it can be hard to discern which masks are real and which are counterfeit. To help, experts share 12 steps you can take to determine whether a mask is real or fake.

    How Covid-19 will impact the supply chain

    Why are there so many fake masks?

    In the early days of the pandemic, medical facilities and states searched desperately for medical supplies amid a shortage of personal protective equipment. During that time, some organizations spent millions on counterfeit N95 masks—and nearly two years later, the United States is still full of fake N95 masks.

    In fact, ECRI, a nonprofit that advises hospitals and health care agencies on product safety, in September 2020 reported that between 60% to 70% of KN95 masks it tested were not effective against 95% of particles they claimed to filter out. 

    Similarly, a November 2021 analysis of sales data published by Jungle Scout found that only a few of the 50 best-selling KN95 masks on Amazon were legitimate.

    And consumers must navigate these counterfeits amid health officials' recommendation that N95, KN95, and KF94 respirator masks provide greater protection against Covid-19 than cloth masks, Newsweek reports.

    How to tell if a mask is fake

    CDC on Wednesday announced it will soon update its mask guidance to "best reflect the multiple options available to people and the different levels of protection they provide." Until then, with so many counterfeit masks circulating, experts suggest taking these 12 steps to help determine whether a mask is real or fake:

    1. Check for tamper-evident packaging.

    Typically, legitimate masks have been sealed in such a way that it should be obvious whether anyone other than the manufacturer has handled the mask, the New York Times' "Wirecutter" reports. For example, if a mask comes in a bag that has been resealed or tied shut, it is likely counterfeit.

    2. Look for manufacturer information.

    Manufacturers typically include information that can be used to contact them so that they can address any questions or concerns customers have about the masks, "Wirecutter" reports—which means the absence of such information can be considered suspect.

    3. Make sure there is an expiration date.

    Similarly, according to "Wirecutter," legitimate masks should always have an expiration date listed somewhere on the packaging.

    4. Look for official terminology that is used incorrectly.

    For example, if a KN95 of KF94 mask claims to be approved by CDC, it's counterfeit, Newsweek reports.

    "This statement is misleading because CDC, through NIOSH [the National Institute for Occupational Safety and Health], does not approve KN95 masks or any other respiratory protective device certified to international standards," CDC wrote.

    And while NIOSH does approve legitimate N95 masks, which must also be "authorized or cleared" by FDA, according to "Wirecutter," those agencies do not provide so-called certificates of approval for N95s, KN95s, or KF94s.

    Further, while KN95 and KF94 packaging may legitimately advertise themselves as "FDA-registered" or "FDA-listed," this is not a meaningful bar of approval, "Wirecutter" reports—it means only that the maker has submitted paperwork to FDA, not that the masks have been tested or approved.

    5. Be skeptical if the company tries too hard (or not at all).

    According to CDC's National Personal Protective Technology Laboratory (NPPTL), if the packaging says "genuine," "legitimate," "authentic," or "reputable," consumers should be skeptical.

    6. Check for branding.

    The name of the company or logo should be somewhere on the mask.

    "Commercially speaking, companies are in the mask business to build brand loyalty and generate sales," Miller said—and a mask with no branding contradicts that goal.

    7. Look for quality-control issues.

    Quality-control issues such as a crooked nose-bridge wire or elastics that lose their stretch or detach easily would alter the fit and consistency of the mask and wouldn't pass a reputable brand's inspection.

    8. Make sure the NIOSH is on any N95 mask.

    When consumers look at N95 masks specifically, they should be able to find the NIOSH mark spelled correctly and clearly in block lettering, "Wirecutter" reports.

    9. Look for an approval number on N95 masks.

    Similarly—and only for N95 masks specifically—consumers should check for an approval number that starts with "TC-84A," followed by four additional digits, either on the mask or the bands.

    If you find this code, you can look for it on the NIOSH Certified Equipment List. However, some counterfeiters might steal an existing number from a legitimate brand. 

    10. For N95 masks, check for ear loops.

    Legitimate N95 masks don't have ear loops—they have a pair of elastic bands that loop around the back of the head to create a better seal, according to "Wirecutter."

    11. Make sure any N95 mask isn't labeled for children.

    Only adult-sized masks go through the NIOSH approval process and can be designated as N95s. As a result, according to "Wirecutter," anything claiming to be a "Kids N95" mask is counterfeit.

    However, legitimate KN95 and KF94 masks do come in children's sizes. 

    12. Look for the GB marking on KN95 masks.

    According to KN95 standards, masks made after July 1, 2021, must be stamped with GB2626-2019.

    If a mask's GB number ends in 2006, that means it was made according to the previous standard—but it is still legitimate if the expiration date has not yet passed. (Chen, "Wirecutter," New York Times, 1/13; Jackson, Newsweek, 1/13)

    Learn more: How Covid-19 will impact the supply chain

    supply chain

    Covid-19 has revealed critical shortcomings in the health care supply chain. Shortages of personal protective equipment (PPE), ventilators, and other vital supplies have hindered the U.S. health care system‘s response to this crisis, and additional waves of shortages are likely in coming months.

    Read our take to learn three requirements for a more resilient, transparent supply chain in light of Covid-19.

    Download Now

    Have a Question?

    x

    Ask our experts a question on any topic in health care by visiting our member portal, AskAdvisory.