FDA product code SHM: Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe

SHM is the FDA product code for interim reprocessing cleaning and intermediate-level disinfection wipe. It is a Class II device, regulated under 21 CFR 880.6891 and reviewed by the General Hospital panel. Devices under SHM reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for SHM devices

openFDA lists no recalls for product code SHM.

Frequently asked questions

What is FDA product code SHM?

SHM is the FDA product code for interim reprocessing cleaning and intermediate-level disinfection wipe. It is a Class II device, regulated under 21 CFR 880.6891 and reviewed by the General Hospital panel.

What device class is SHM?

Class II, regulation 21 CFR 880.6891. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SHM
• Run a recall and safety report across every SHM manufacturer
• Watch product code SHM for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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