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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 K000179
Device Name NUZONE NITRILE SURGICAL GLOVES POWDER FREE
Applicant
TERANG NUSA SDN BHD
1 JALAN 8, PENGKALAN CHEPA 2
INDUSTRIAL ZONE,
KOTA BHARU, KELANTAN,  MY 16100
Applicant Contact CHIN-GUAN LOW
Correspondent
TERANG NUSA SDN BHD
1 JALAN 8, PENGKALAN CHEPA 2
INDUSTRIAL ZONE,
KOTA BHARU, KELANTAN,  MY 16100
Correspondent Contact CHIN-GUAN LOW
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/20/2000
Decision Date 05/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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