
Omni Intl., Inc.
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OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM is an FDA 510(k)-cleared medical device (K984066) manufactured by Omni Intl., Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 12, 1999. Regulation: 8.