K160928

Substantially Equivalent

Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)

Applicant: Hartalega Sdb. Bhd.
Product code: KGO
Advisory panel: General, Plastic Surgery
Date received: 2016-04-04
Decision date: 2016-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bandar Sri Damansara, MY

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Data sourced from openFDA. This site is unofficial and independent of the FDA.