SUNNY TEX (PATIENT EXAMINATION GLOVES)

SUNNY TEX (PATIENT EXAMINATION GLOVES) is an FDA 510(k)-cleared medical device (K892021) manufactured by P.T. Indotama Megah Indah Rubber. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 14, 1989. Regulation: 8.