Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs— 510(k) K214074

Name: FDA 510(k) clearance K214074
Creator: U.S. Food and Drug Administration
Published: 2022-05-26

Substantially Equivalent

Hartalega NGC Sdn. Bhd.

FDA 510(k) clearance K214074 for Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs, Substantially Equivalent on 2022-05-26. Applicant: Hartalega NGC Sdn. Bhd.. Device class: 1.

Clearance details

Applicant: Hartalega NGC Sdn. Bhd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2021-12-27
Decision date: 2022-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sepang, MY

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