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# Certain Surgical Apparel 510(k) Exempt
- URL: https://www.fdaweb.com/certain-surgical-apparel-510-k-exempt/
- Published: 2018-05-17T12:00:00.000Z
- Updated: 2026-09-15T00:05:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141468

*Federal Register* notice: FDA has published a final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the 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. The exemption is intended to decrease regulatory burden on the medical device industry and will eliminate private costs and expenditures required to comply with certain federal regulations. All other Class 2 devices classified under FDA’s surgical apparel classification regulation continue to be subject to premarket notification requirements. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-05-17/pdf/2018-10563.pdf?ref=fdaweb.com).