QWS

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Foam Or Gel Chemical Sterilant/High Level Disinfectant

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6886

Medical specialty

General Hospital

FDA definition

A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use.

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