TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE

TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE is an FDA 510(k)-cleared medical device (K897192) 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 February 14, 1990. Regulation: 8.