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Halyard Health

FDA Revokes Emergency Use Authorization for KN95 Masks

Official FDA Release 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

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HALYARD Fluidshield Surgical N95

What’s The Difference: Surgical Masks vs N95 Respirators

Surgical Mask N95 Respirator Approval and Regulations Cleared by the U.S. Food and Drug Administration (FDA) and regulated under 21 CFR 878.4040. Regulated by the FDA, CDC NIOSH, OSHA. Evaluated, tested, and approved by NIOSH as per the requirements in 42 CFR Part 84. Intended Purpose Fluid resistant. Reduces wearer’s

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