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# Not All Scrubs are Medical Devices: Petition
- URL: https://www.fdaweb.com/not-all-scrubs-are-medical-devices-petition/
- Published: 2020-12-14T12:00:00.000Z
- Updated: 2026-09-14T16:40:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148298

A just-filed [citizen petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2020-P-2289-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) is requesting that FDA not treat “daily-wear uniform scrubs” as medical devices. The petition, which was filed by the law firm Loeb & Loeb on behalf of an unnamed garment maker, is asking for enforcement discretion for the scrubs that are “intended for every day wear as a general work uniform by personnel in healthcare settings such as hospitals, medical and dental offices, veterinary clinics, clinical laboratories, etc.” It also asks that FDA not consider the scrubs as devices even if they incorporate an antimicrobial component solely for purposes of protecting the garment.

The petition specifically takes issue with a recent guidance entitled *Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency.* “FDA arguably appears to take a much broader view of the criteria by which certain apparel can be regulated as a device, including by reason of the mere fact that such garments are intended for use by any healthcare professionals,” the petition contends. It asks FDA not to regulate scrubs as devices if: 

- The scrubs are manufactured with an EPA-registered antimicrobial ingredient as a component of the garment;
- The antimicrobial component is solely intended, and is only described in labeling, marketing and promotional materials, for non-medical purposes, such as protecting the garment itself and/or enhancing the wearability or durability of the garment by, for example, reducing the accumulation of odors, resisting stains, protecting against color fading, and similar purposes; and
- The scrubs are not labeled or marketed with claims referencing any specific pathogen, virus, or infectious agent, or with claims that the garment will prevent, control, or reduce the spread of any infectious or communicable disease.