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Surgical mask definition expanded

This article was originally published in The Gray Sheet

Executive Summary

1Surgical mask final 510(k) guidance clarifies that its scope includes "surgical masks" and "surgical N95 NIOSH certified respirators," following comments from 3M and University of Minnesota Industrial Hygiene Program Director Lisa Brosseau criticizing FDA's use of the term "N95 respirators." The March 5 guidance also incorporates changes based on Cardinal Health and Kimberly-Clark comments submitted in response to the May 2003 draft - a 1998 guidance FDA re-issued to formally solicit comments (2"The Gray Sheet" May 19, 2003, p. 17)...

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