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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 K051094
Device Name NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE
Applicant
Terang Nusa Sdn Bhd
1, Jalan 8,
Pengkalan Chepa 2 Ind. Zone
Kota Bharu, Kelantan,  MY 16100
Applicant Contact LOW CHIN GUAN
Correspondent
Terang Nusa Sdn Bhd
1, Jalan 8,
Pengkalan Chepa 2 Ind. Zone
Kota Bharu, Kelantan,  MY 16100
Correspondent Contact LOW CHIN GUAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/28/2005
Decision Date 06/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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