SHM — Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe Class II
FDA product code SHM covers "Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe", a Class II medical device regulated under 21 CFR 880.6891. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SHM
- Device Class
- Class II
- Regulation Number
- 880.6891
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
An interim reprocessing cleaning and intermediate-level disinfection wipe is intended for use by a health care provider to clean and intermediate-level disinfect medical device types indicated on the labeling as an interim step prior to sterilization or high-level disinfection. This is intended as a non-terminal disinfection step compatible with subsequent terminal reprocessing such as sterilization or high-level disinfection and renders the device safe to handle by the user compared to unprocessed, clinically soiled devices. Safe to handle is limited in scope to mean the device has been appropriately intermediate-level disinfected.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240075 | steris | Prolystica Pass Thru Disinfectant Wipes | May 1, 2026 |