These KN95 respirators have been NIOSH/NPPTL* tested for filtration efficiency with results showing filtration performance equivalent to N95 respirators. They are listed in Appendix A of the FDA’s Letter of Authorization - Umbrella EUA: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China and thereby authorized by the FDA for use by healthcare personnel in healthcare settings to prevent exposure to pathogenic biological airborne particulates during the COVID-19 pandemic.
These KN95 respirators are included in Appendix A and are thereby authorized for medical use during the COVID-19 pandemic. Their package label and Instructions for Use describe them as a “non-medical” product. This discrepancy results from the fact that the label “non-medical” is required by the Chinese government for exportation.
Beware of vendors advertising “FDA Approved” or “FDA Certified” KN95 masks. The FDA neither “approves” nor “certifies” KN95 respirators. The FDA only “authorizes” specific KN95 respirator models for use by healthcare workers in healthcare settings during the COVID-19 epidemic. The only KN95 masks that the FDA authorizes for such use are those listed in Appendix A . If a vendor does not reveal the manufacturer of their KN95 mask, you cannot confirm that the mask is authorized by the FDA. A certificate with the FDA logo on it, such as this Certificate of Registration, means only that an outside agent has registered the manufacturer and listed the mask with the FDA. Such a listing does not confer, affirm, or assert FDA “approval”, “certification” or “authorization.” Use of unauthorized masks by healthcare workers in healthcare settings is not recommended because the masks may have substandard filtration capacity.
*NIOSH–National Institute for Occupational Safety and Health/NPPTL–National Personal Protective Technology Laboratory