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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K003547
Device Name NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
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
LYY  
Date Received11/17/2000
Decision Date 12/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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