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Ansell Healthcare Products, Inc.
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MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES is an FDA 510(k)-cleared medical device (K013604) manufactured by Ansell Healthcare Products, 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 12, 2001. Regulation: 8.