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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 K990840
Device Name NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
Applicant
Terang Nusa Sdn Bhd
1 Jalan 8, Pengkalan Chepa 2, Industrial Zone
Kota Bharu,  MY 16100
Applicant Contact CHIN-GUAN LOW
Correspondent
Terang Nusa Sdn Bhd
1 Jalan 8, Pengkalan Chepa 2, Industrial Zone
Kota Bharu,  MY 16100
Correspondent Contact CHIN-GUAN LOW
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/15/1999
Decision Date 05/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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