On June 30, 2021, the U.S. Food and Drug Administration (FDA) announced the revocation of Emergency Use Authorizations (EUAs) for the following products:
- “Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)”
As of the listed effective date, these devices are no longer authorized for use in health care settings by health care personnel.
The announcement can be found here:
CSMS #48653470 can be found here: