
Intl. Trade Management Co.
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POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES is an FDA 510(k)-cleared medical device (K954462) manufactured by Intl. Trade Management Co.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 12, 1995. Regulation: 8.