SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES

SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES is an FDA 510(k)-cleared medical device (K994248) manufactured by Shinemound Enterprise, Inc.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 27, 2000. Regulation: 8.