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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 K935256
Device Name PATIENT EXAMINATION GLOVES
Applicant
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
LOT 821, JALAN MATANG
TAIPING, PERAK DARUL RIDZUAN,  MY 34750
Applicant Contact CHEE YONG FOO
Correspondent
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
LOT 821, JALAN MATANG
TAIPING, PERAK DARUL RIDZUAN,  MY 34750
Correspondent Contact CHEE YONG FOO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/01/1993
Decision Date 03/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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