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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 K083571
Device Name ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
Applicant
Purna Bina Sdn Bhd
1a Jalan 8
Pengkalan Chepa 2 Ind Zone
Kluang, Johor,  MY 86007
Applicant Contact ROBERT HILL
Correspondent
Purna Bina Sdn Bhd
1a Jalan 8
Pengkalan Chepa 2 Ind Zone
Kluang, Johor,  MY 86007
Correspondent Contact ROBERT HILL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/03/2008
Decision Date 08/13/2009
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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