21 CFR 880.6891 — Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe

General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6891

Identification

Prolystica Pass Thru Disinfectant Wipes are a ready-to-use (RTU) one-step cleaner and intermediate level disinfectant. They are intended for use in hospitals and other healthcare facilities to clean and intermediate level disinfect non-submersible and/or heat-sensitive critical and semi-critical medical devices or medical device components as an interim step prior to sterilization or high-level disinfection. They are not intended for use on flexible endoscopes or as a terminal sterilization or high-level disinfection processing step.

Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls. Class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes