DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM

DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM is an FDA 510(k)-cleared medical device (K013302) manufactured by Allegiance Healthcare Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 16, 2001. Regulation: 8.