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  • Writer's pictureKBM

URGENT FDA Notice Regarding Filtering Facepiece Respirators (FFPs)

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:

A webinar for factors to be considered when purchasing respirators from another country, produced by CDC/NIOSH can be found here:

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