GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)

GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) is an FDA 510(k)-cleared medical device (K001047) manufactured by Guthrie Medicare Products (Melaka) Sdn Bhd. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 27, 2000. Regulation: 8.