> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Safety Concerns on China Facepiece Respirators
- URL: https://www.fdaweb.com/fda-safety-concerns-on-china-facepiece-respirators/
- Published: 2020-05-07T12:00:00.000Z
- Updated: 2026-09-14T16:14:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146742

FDA says it is concerned that certain filtering facepiece respirators from China may not provide consistent and adequate respiratory protection to health care personnel exposed to Covid-19 based on filtration performance testing conducted by CDC’s National Institute for Occupational Safety and Health (NIOSH). Because of the concerns, the agency revised and reissued a 4/3 emergency use authorization (EUA) for such respirators ([Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China](https://www.fda.gov/media/136664/download?ref=fdaweb.com)) to revise eligibility criteria, according to an [FDA notice](https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter?utm%5Fcampaign=2020-05-07%20Concerns%20with%20Filtering%20Facepiece%20Respirators%20from%20China%20-%20Letter%20to%20HCP&utm%5Fmedium=email&utm%5Fsource=Eloqua). A number of the respirators failed to demonstrate a minimum particulate filtration efficiency of 95% in [testing conducted](https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html?ref=fdaweb.com) at NIOSH and have been removed from the EUA's appendix. The agency notes that the devices not meeting the performance standard can be re-labeled as face masks and authorized if certain criteria are met under the [Face Mask umbrella](https://www.fda.gov/media/137121/download?ref=fdaweb.com) EUA.