
Pt. Eka Wira Asia
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NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) is an FDA 510(k)-cleared medical device (K980729) manufactured by Pt. Eka Wira Asia. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 1, 1998. Regulation: 8.

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