LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS

LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS is an FDA 510(k)-cleared medical device (K011749) manufactured by Sempermed USA, Inc.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 21, 2001. Regulation: 8.