POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE— 510(k) K161008

Substantially Equivalent

Hartalega Sdn Bhd

FDA 510(k) clearance K161008 for POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE, Substantially Equivalent on 2016-07-28. Applicant: Hartalega Sdn Bhd.

Clearance details

Applicant: Hartalega Sdn Bhd
Product code: Code KGO
Advisory panel: General, Plastic Surgery
Date received: 2016-04-11
Decision date: 2016-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bandar Sri Damansara, MY

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