Foam Or Gel Chemical Sterilant/High Level Disinfectant
Medical specialty
General Hospital
Device class
2
Regulation number
880.6886
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.