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.

Details

• 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.
• Document Type:
  Report
• CIO:
  NIOSH
• Division:
  NIOSH_NPPTL
• NIOSHTIC Number:
  nn:na
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:70eefbeee8d3bcf6f37093f5dd1662441b58713242d0c5fb54f3d61d10e99d2bfb23dc84237dc0621d67ca8b8f50ad551fff7888df0e37a5b2269833c92f9857
• Download URL:
  https://stacks.cdc.gov/view/cdc/137585/cdc_137585_DS1.pdf
• File Type:
  [PDF - 274.00 KB ]