Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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)...

Related Content




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts