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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 K033530
Device Name ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Asia Pacific Latex Sdn Bhd
Lot 12, Medan Tasek,
Tasek Industrial Estate
Ipoh Perak,  MY 31400
Applicant Contact LEE SON HONG
Correspondent
Asia Pacific Latex Sdn Bhd
Lot 12, Medan Tasek,
Tasek Industrial Estate
Ipoh Perak,  MY 31400
Correspondent Contact LEE SON HONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/10/2003
Decision Date 01/28/2004
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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