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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 K110698
Device Name NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
Applicant
Terang Nusa Sdn Bhd
1, Jalan 8,
Pengkalan Chepa 2 Ind. Zone
Kota Bharu, Kelantan,  MY 16100
Applicant Contact ROBERT HILL
Correspondent
Terang Nusa Sdn Bhd
1, Jalan 8,
Pengkalan Chepa 2 Ind. Zone
Kota Bharu, Kelantan,  MY 16100
Correspondent Contact ROBERT HILL
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/17/2011
Decision Date 12/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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