KBM
May 8, 20201 min
The FDA revised one criterion for Emergency Use Autorization (EUA) for Non-NIOSH-Approved
disposable FFPs manufactured in China. As a result, several respirators failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH. Therefore, these have been removed from Appendix A as they may not reliably provide a minimum percent particulate filtration efficiency and cannot be reliably decontaminated. Please refer to the NIOSH page for the results and removed companies: https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
Please view the FDA letter in its entirety here: https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter.
A webinar for factors to be considered when purchasing respirators from another country, produced by CDC/NIOSH can be found here: https://www.cdc.gov/niosh/npptl/webinars/Webinar-Factors-To-Consider.html