FDA Product Code MLR: Sterilizer, Chemical

Under FDA product code MLR, chemical sterilizers are cleared for the sterilization of heat-sensitive medical instruments and endoscopes.

These systems use gaseous or liquid chemical agents — including ethylene oxide, hydrogen peroxide plasma, and peracetic acid — to achieve sterilization of devices that would be damaged by the high temperatures of steam autoclaving.

MLR devices are Class II medical devices, regulated under 21 CFR 880.6860 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Steris, Advanced Sterilization Products, Inc. and STERIS Corporation.