SHM

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6891

Medical specialty

General Hospital

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.

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