Product code SHM— Unknown
Prolystica Pass Thru Disinfectant Wipes
- Classification name
- Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe
- Device class
- Class 2
- Regulation
- 21 CFR 880.6891
- Advisory panel
- Unknown
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SHM
FDA has cleared device under product code SHM, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SHM
Recent clearances under product code SHM
Data sourced from openFDA. This site is unofficial and independent of the FDA.