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# FDA Proposes 510(k) Exemption for Surgical Apparel
- URL: https://www.fdaweb.com/fda-proposes-510-k-exemption-for-surgical-apparel/
- Published: 2017-11-30T12:00:00.000Z
- Updated: 2026-09-14T23:04:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140232

*Federal Register* notice: FDA has announced its intent to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use, disposable respiratory protective devices used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators and surgical N95 respirators are currently regulated by FDA under product code MSH. All other Class 2 devices classified under FDA’s surgical apparel classification regulation would continue to be subject to premarket notification requirements. Comments on the proposal are being accepted until 1/29/2018\. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-30/pdf/2017-25781.pdf?ref=fdaweb.com).