FDA 510(k) clearance · back to tracker

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

Hartalega Sdn Bhd cleared K201748 on 2020-10-02, decision: substantially equivalent

K-number

K201748

Sponsor

Hartalega Sdn Bhd

Device

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

Class

Class I

Decision

Substantially Equivalent

Decision date

2020-10-02

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K201748on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.