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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 K062527
Device Name BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Applicant
Multisafe Sdn. Bhd.
Lot 764
Bidor Industrial Estate
35500 Bidor, Perak Darul Ridzu,  MY 35500
Applicant Contact ABD HADI BIN HUSIN
Correspondent
Multisafe Sdn. Bhd.
Lot 764
Bidor Industrial Estate
35500 Bidor, Perak Darul Ridzu,  MY 35500
Correspondent Contact ABD HADI BIN HUSIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/28/2006
Decision Date 02/20/2007
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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