
Lowenkamp Intl., Inc.
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SANOFLEX-STERILE LATEX SURGICAL GLOVES is an FDA 510(k)-cleared medical device (K903513) manufactured by Lowenkamp 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 September 13, 1990. Regulation: 8.