ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) is an FDA 510(k)-cleared medical device (K003771) manufactured by Ansell Healthcare Products, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 15, 2001. Regulation: 8.