Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities

June 30, 2021

“The U.S. Food and Drug Administration (FDA) is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. “

This decision is mostly based on the fact that domestic supply of authorized respirators are now more prevalent which is great news. 

If you need N95 masks, one of our main suppliers recently built an N95 factory in Texas and is supplying NIOSH N95 masks regularly without supply chain challenges. We’re glad to send you samples.

Click here to read the full FDA announcement.

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