TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED

TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED is an FDA 510(k)-cleared medical device (K903987) 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 October 10, 1990. Regulation: 8.