NIOSH Respiratory Protective Device Information, CA 2021-1033R1 - Guidance for respirator users regarding NIOSH Approved surgical N95 filtering facepiece respirators (surgical N95s) exempt from 510(k) pre- market notification in accordance with the Food and Drug Administration regulations at 21 CFR § 878.4040. Supersedes March 2021 version.
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NIOSH Respiratory Protective Device Information, CA 2021-1033R1 - Guidance for respirator users regarding NIOSH Approved surgical N95 filtering facepiece respirators (surgical N95s) exempt from 510(k) pre- market notification in accordance with the Food and Drug Administration regulations at 21 CFR § 878.4040. Supersedes March 2021 version.

  • 06/09/2021

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  • Description:
    Since August 24, 2020, the National Institute for Occupational Safety and Health (NIOSH) has accepted and prioritized approval applications for surgical N95 filtering facepiece respirators (surgical N95s), a subset of single-use dispoasable N95 filtering facepiece respirators (FFRs). NIOSH-approved N95 FFRs are also regulated by the Food and Drug Administration (FDA) as class II devices under 21 CFR § 878.4040, classified as product code MSH, and commonly referred to as surgical N95s. This notice is intended to inform users about a subset of surgical N95s, exempted by regulation from the FDA’s premarket notification (510(k)) requirements. This subset of NIOSH Approved surgical N95s are easily identified by the NIOSH approval labels.
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    Report
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    NIOSH
  • Division:
    NIOSH_NPPTL
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