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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K260312
Device Name Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid
Applicant
Gmp Medicare Sdn. Bhd.
Lot/Pt 64593, Jalan Dahlia/Ku8,
Kawasan Perindustrian Meru Timur
Klang,  MY 41050
Applicant Contact Ummi Salmah Othman
Correspondent
Gmp Medicare Sdn. Bhd.
Lot/Pt 64593, Jalan Dahlia/Ku8,
Kawasan Perindustrian Meru Timur
Klang,  MY 41050
Correspondent Contact Ummi Salmah Othman
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received01/30/2026
Decision Date 09/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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