QBW

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Surgical Apparel With Material Claims

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4040

Medical specialty

General, Plastic Surgery

FDA definition

Surgical apparel with material claims are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Surgical apparel with material claims contain components that have been constructed, treated, modified, and/or coated with substances that are intended or known to create or enhance a functional element of the device. Examples include fluid repellency, soil retention, or antimicrobial activity.

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