# Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel
> **Food and Drug Administration** · Final order. · Published 2018-05-17 · Effective 2018-05-17 · 83 FR 22846
## Document
- **Document number:** 2018-10563
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 83 FR 22846
- **CFR reference:** 21 CFR 878
- **Publication date:** 2018-05-17
- **Effective date:** 2018-05-17
- **HHS docket:** Docket No. FDA-2017-N-4919
## Abstract

The Food and Drug Administration (FDA or Agency) is publishing this 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 (RPD) 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 (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. This exemption will 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 II devices classified under FDA's surgical apparel classification regulation continue to be subject to premarket notification requirements. FDA is also amending the codified language for the surgical apparel devices classification regulation to reflect this final determination.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2018/05/17/2018-10563/medical-devices-exemption-from-premarket-notification-class-ii-devices-surgical-apparel)
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