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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 K161932
Device Name Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
Applicant
Terang Nusa Sdn Bhd
1 Jalan 8, Pengkalan Chepa 2, Industrial Zone
Kota Bharu,  MY 16100
Applicant Contact Robert Hill
Correspondent
Terang Nusa Sdn Bhd
1 Jalan 8, Pengkalan Chepa 2, Industrial Zone
Kota Bharu,  MY 16100
Correspondent Contact Robert Hill
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/14/2016
Decision Date 11/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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