Hospitals and healthcare facilities across the United States are facing shortages of NIOSH-approved N95 masks. As a result, manufacturers around the world have ramped up efforts to produce NIOSH-certified respirators, and the FDA has authorized importation and use of disposable respirators made in and regulated by China, including KN95 masks. These masks have similar performance characteristics and are effective PPE for those on the front lines of this global pandemic.
ISEA members have volunteered time, resources, and expertise to assess the compliance of KN95 masks. Recent testing revealed some product offerings are falling below the 95% filtration efficiency rate, proving substandard, nonperforming, and ultimately dangerous. In one case, an ISEA member found masks to range from 45% – 30% in efficiency. This catastrophically inadequate product was marked as FDA approved, making it fraudulent and illegal.
PPE manufacturers and distributors are a vital trusted partner for their customers. Everyone should be able to trust that standardized, certified PPE will perform to the level of protection to which it attests. ISEA and its members will continue to prioritize the safety and health of our customers through rigorous standardization, and we are working closely with the federal government to remove substandard and fraudulently marked products from the supply chain.
The National Personal Protective Technology Laboratory (NPPTL) created the International Respirator Assessment program to assess the filter efficiency performance of international respirator products for federal and state agencies, employers, and healthcare systems. These assessments are not a part of the NIOSH respirator approval process and will in no way lead to or preclude NIOSH approval through the official approval process.
NPPTL has completed assessments for many products; results are listed here.
Requests for samples to be tested can be submitted here.
The FDA has provided a list of authorized respirators imported from China. For the most current CDC recommendations on optimizing respirator use, please visit CDC’s Strategies for Optimizing the Supply of N95 Respirators.
Counterfeit respirators are products that are falsely marketed and sold under recognized and trademarked brand names, or as being NIOSH-approved. When NIOSH becomes aware of counterfeit respirators or those misrepresenting NIOSH approval on the market, they are posted here to alert users, purchasers, and manufacturers.