How to Recognize a Counterfeit N95 Mask
By Alexandra Serban
June 09, 2020
In spite of manufacturers’ efforts to ramp up N95 mask production, noncompliant versions are being sold in stores and online, the CDC warns in a recent notice. How to identify counterfeit respirators? Here are some cues to be aware of to assist you in identifying non-compliant N95 respirators before purchasing.
But first, who certifies N95 masks?
Most N95 respirators are used in construction and industrial environments to protect workers from hazardous particulates.
They are regulated by the National Personal Protective Technology Laboratory (NPPTL), part of the National Institute for Occupational Safety and Health (NIOSH). NIOSH is part of the Centers for Disease Control and Prevention (CDC).
Established in 1970, NIOSH uses Standard Test Procedure TEB-APR-STP-0059 to confirm filter efficiency (greater than or equal to 95% efficiency) of N95 filters. But there are a lot more functional requirements for a product to ensure the workers’ health and achieve NIOSH approval.
Signs of authenticity
A NIOSH-approved respirator has an approval label that comes with the packaging – on the box or within the user instructions.
All approved masks will also present the following markings:
· Name of approval holder/manufacturer name, e.g., Honeywell
· The word “NIOSH” in block letters or the NIOSH logo.
· NIOSH Testing and Certification approval number, e.g., TC-84A-XXXX.
· NIOSH filter series and filter efficiency level, e.g., N95, N99 etc.
· Model number or part number: e.g., 8210.
Source: cdc.gov. Reference to images from the CDC site does not constitute endorsement or recommendation by the U.S. Government, Department of Health and Human Services, or Centers for Disease Control and Prevention.
NIOSH recommends the lot number and/or date of manufacture also be included, however, this is not mandatory.
Signs of fraud
The first sign of a potentially non-compliant mask are the words “meets NIOSH standard”, "N95-Approved", “legitimate” or “genuine” written on the box.
Additional visual indicators:
1. The lack of NIOSH markings or incomplete markings
2. No TC approval number on the respirator or the headband
3. NIOSH may be spelled incorrectly
4. Decorative materials
It’s worth mentioning that any alteration from the originally-approved version, such as changing the way a mask is secured to the face, material used or design, needs to pass NIOSH approval.
“In accordance with the NIOSH regulation, 42 CFR Part 84, Approval of Respiratory Protective Devices, any changes a manufacturer wishes to make to NIOSH-approved respirators must first be evaluated and approved by NIOSH”, this CDC letter reads. A counterfeit mask can also hide under a valid TC code belonging to a reputable company.
A word of caution on third-party marketplaces
If you intend to purchase respirators from auction sites or third-party distributors, make sure to verify seller reviews. Huge price fluctuations may also be a sign of suspicion. Stock availability in times of high demand may raise eyebrows, too.
Here are some additional resources to help you:
A list of NIOSH-approved N95 respirators -https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.html
A list of approved Surgical N95 masks- https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource3surgicaln95.html