
Hartalega Sdn Bhd
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FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES is an FDA 510(k)-cleared medical device (K022671) manufactured by Hartalega Sdn Bhd. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 17, 2002. Regulation: 8.

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