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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 K262542
Device Name Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim
Applicant
Top Glove Sdn. Bhd.
Lot 4969, Jalan Teratai, Batu 6, Off Jalan Meru
Klang,  MY 41050
Applicant Contact Noor Akilah Saidin
Correspondent
Top Glove Sdn. Bhd.
Lot 4969, Jalan Teratai, Batu 6, Off Jalan Meru
Klang,  MY 41050
Correspondent Contact Noor Akilah Saidin
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received07/23/2026
Decision Date 09/09/2026
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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