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SHMClass II

Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe

21 CFR 880.6891 / General Hospital
FDA source (opens on fda.gov)

SHM is the FDA product code for Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe, a class II device type, regulated under 21 CFR 880.6891. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SHM
Device name
Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe
FDA 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.
Regulation
21 CFR 880.6891
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SHM

By decision year
1 clearance under product code SHM with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SHM by decision year
YearClearances
20261

Applicants with the most clearances

Product code SHM
Applicants holding the most 510(k) clearances under product code SHM
ApplicantClearances
STERIS Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code