
Ergo Intl., Ent., Inc.
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ERGO II, SURGICAL LATEX GLOVES is an FDA 510(k)-cleared medical device (K884030) manufactured by Ergo Intl., Ent., Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 6, 1988. Regulation: 8.