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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 K001094
Device Name SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
Applicant
JB STAR SDN BHD
3A JALAN CEKOR, TAMAN SRI AMAR
JOHOR BARUE, JOHOR,  MY 81100
Applicant Contact LOOI CHIN SWEE
Correspondent
JB STAR SDN BHD
3A JALAN CEKOR, TAMAN SRI AMAR
JOHOR BARUE, JOHOR,  MY 81100
Correspondent Contact LOOI CHIN SWEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/04/2000
Decision Date 04/28/2000
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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