SHM · Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe
General Hospital · 21 CFR 880.6891 · Class 2
Overview
| Product Code | SHM |
|---|---|
| Device Name | Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe |
| Regulation | 21 CFR 880.6891 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
Prolystica Pass Thru Disinfectant Wipes are a ready-to-use (RTU) one-step cleaner and intermediate level disinfectant. They are intended for use in hospitals and other healthcare facilities to clean and intermediate level disinfect non-submersible and/or heat-sensitive critical and semi-critical medical devices or medical device components as an interim step prior to sterilization or high-level disinfection. They are not intended for use on flexible endoscopes or as a terminal sterilization or high-level disinfection processing step.
Classification Rationale
FDA has determined that the device can be classified in Class II with the establishment of special controls. Class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN240075 | Prolystica Pass Thru Disinfectant Wipes | Steris | May 1, 2026 | DENG |
Top Applicants
- Steris — 1 clearance
