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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K221718
Device Name Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
Applicant
Hartalega NGC SDN BHD
NO. 1, Persiaran Tanjung
Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Applicant Contact Kuan Mun Leong
Correspondent
Hartalega NGC SDN BHD
NO. 1 Persiaran Tanjung
Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Correspondent Contact Nurul Aisyah Kong
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received06/13/2022
Decision Date 09/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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