Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs— 510(k) K201748

Substantially Equivalent

Hartalega Sdn Bhd

FDA 510(k) clearance K201748 for Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs, Substantially Equivalent on 2020-10-02. Applicant: Hartalega Sdn Bhd.

Clearance details

Applicant
Hartalega Sdn Bhd
Product code
Code KGO
Advisory panel
General, Plastic Surgery
Date received
Decision date
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.