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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 K990488
Device Name SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
Applicant
Terang Nusa Sdn Bhd
Lot E4(4), Jalan 8
Pengkalan Chepa Ii Ftz
Kota Bharu, Kelantan,  MY 16100
Applicant Contact CHIN GUAN LOW
Correspondent
Terang Nusa Sdn Bhd
Lot E4(4), Jalan 8
Pengkalan Chepa Ii Ftz
Kota Bharu, Kelantan,  MY 16100
Correspondent Contact CHIN GUAN LOW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/16/1999
Decision Date 05/28/1999
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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