How to Know If an N95 Respirator is Real or Counterfeit

  |   March 26, 2020

As the supply of N95 respirators for healthcare workers continues to dwindle, a number of counterfeit or uncertified respirators are beginning to surface in the marketplace. If a hospital is struggling to maintain its supply of N95 respirators, there are other options that can be used in place of the standard N95 respirator. The Centers for Disease Control and Prevention (CDC) has developed guidelines on how to optimize PPE, including N95 respirators.

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If you are purchasing respirators to protect healthcare workers from exposure to the SARS-CoV-2 virus, only respirators certified by the National Institute for Occupational Safety and Health (NIOSH) are recommended. NIOSH’s National Personal Protective Equipment Laboratory tests respirators to determine efficacy and conformance with NIOSH standards. Once certified, the respirator is listed on NIOSH’s Certified Equipment List with an Approval Number. Respirators on this list are considered certified and appropriate for their intended use. The graphic below illustrates the information that should be supplied on any NIOSH certified N95 respirator.

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Information Supplied on NIOSH Certified N95 Respirators

Click image to enlarge
Source: https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/default.html

The CDC has published guidance on how to identify counterfeit N95 respirators. Verification of the manufacturer is key in evaluating whether a product and manufacturer are legitimate.

Below are some examples of counterfeit respirators identified by the CDC.

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EH&E works with procurement staff for many healthcare organizations to advise on which products are legitimate. If your institution needs assistance, contact us today.
 

CDC Examples of Counterfeit Respirators

This is an example of a misrepresentation of the NIOSH-approval. Yark is not a NIOSH approval holder or a private label holder. Additionally, respirators from the box include the CE (European) approval mark and NIOSH N95. This is not an acceptable format for a NIOSH-approved respirator (3/5/2020) Credit: https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html.

This product is not NIOSH-approved. Look at the markings on the front. The NIOSH logo is wrong, there is no approval number (TC-84A-xxxx). (11/6/2019)

This product is not NOSH approved. No NIOSH logo or approval number on the face of the product. (11/6/2019)