TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE

TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE is an FDA 510(k)-cleared medical device (K913207) manufactured by Baxter Healthcare Corp. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 10, 1991. Regulation: 8.