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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 K102230
Device Name NUGARD NITILE GREY COLOR
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 Number880.6250
Classification Product Code
LZA  
Date Received08/09/2010
Decision Date 09/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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