Product Classification

• Device: foam or gel chemical sterilant/high level disinfectant
• 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.
• Physical State: A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel
• Technical Method: A foam or gel chemical sterilant / high level disinfectant is applied manually or automatically on the surface of medical device to archive high level disinfection
• Target Area: Does not contact patient directly
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: QWS
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 880.6886
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible