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Foam Or Gel Chemical Sterilant/High Level Disinfectant

FDA product code QWS · 1 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.6886
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-05-09 – 2025-05-09

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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