QPC

10 FDA 510(k) clearances · Product code

FDA profile

Official device name

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4040

Medical specialty

General, Plastic Surgery

FDA definition

A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.

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