ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING is an FDA 510(k)-cleared medical device (K031301) manufactured by Cardinalhealth. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 14, 2003. Regulation: 8.