Subject: 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 Final Ruleexternal icon published May 17, 2018.
NIOSH CA 2021-1033

Revised March 2021

Beginning August 24, 2020, the National Institute for Occupational Safety and Health (NIOSH) began accepting and prioritizing approval applications for surgical N95 filtering facepiece respirators (surgical N95s). Since NIOSH Approved surgical N95s are also regulated by the Food and Drug Administration (FDA) under product code MSH and 21 CFR 878.4040, this notice informs users about a subset of surgical N95s, exempted by regulation from the FDA’s 510(k) premarket clearance process. This subset of NIOSH Approved surgical N95s are easily identified by the NIOSH approval labels, see Figures 1 and 2.

Read more>