Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe
SHM · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6891
Classification
FDA Product Code
SHM
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6891
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.