SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)

SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) is an FDA 510(k)-cleared medical device (K010297) manufactured by Maxxim Medical. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 15, 2001. Regulation: 8.