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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 K254285
Device Name Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue
Applicant
Hartalega NGC Sdn. Bhd.
# 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Applicant Contact Kuan Mun Leong
Correspondent
Hartalega NGC Sdn. Bhd.
# 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Correspondent Contact Nor Akmar Yusoff
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ  
Date Received12/31/2025
Decision Date 07/20/2026
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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