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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 K101917
Device Name COMFORT RUBBER GLOVES IND.SDN.BHD.
Applicant
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
LOT 821, JALAN MATANG
TAIPING, PERAK DARUL RIDZUAN,  MY 34750
Applicant Contact TAN KENG BENG
Correspondent
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
LOT 821, JALAN MATANG
TAIPING, PERAK DARUL RIDZUAN,  MY 34750
Correspondent Contact TAN KENG BENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/09/2010
Decision Date 10/29/2010
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
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