Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)— 510(k) K221718

Substantially Equivalent

Hartalega NGC Sdn. Bhd.

FDA 510(k) clearance K221718 for Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural), Substantially Equivalent on 2022-09-24. Applicant: Hartalega NGC Sdn. Bhd..

Clearance details

Applicant: Hartalega NGC Sdn. Bhd.
Product code: Code KGO
Advisory panel: General, Plastic Surgery
Date received: 2022-06-13
Decision date: 2022-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sepang, MY

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