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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 K992557
Device Name QUALATEX POWDERED LATEX EXAMINATION GLOVES
Applicant
Tan Sin Lian Industries Sdn. Bhd.
# 8, Taman Marin
Jalan Haji Abdullah
Muar, Johor,  MY 84000
Applicant Contact TAN TIOW GIN
Correspondent
Tan Sin Lian Industries Sdn. Bhd.
# 8, Taman Marin
Jalan Haji Abdullah
Muar, Johor,  MY 84000
Correspondent Contact TAN TIOW GIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/30/1999
Decision Date 09/14/1999
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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