Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove— 510(k) K183389

Substantially Equivalent

Hartalega NGC Sdn. Bhd.

FDA 510(k) clearance K183389 for Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove, Substantially Equivalent on 2019-06-28. Applicant: Hartalega NGC Sdn. Bhd..

Clearance details

Applicant: Hartalega NGC Sdn. Bhd.
Product code: Code KGO
Advisory panel: General, Plastic Surgery
Date received: 2018-12-06
Decision date: 2019-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sepang, MY

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