Foam Or Gel Chemical Sterilant/High Level Disinfectant
QWS · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6886
Classification
FDA Product Code
QWS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6886
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.