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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer patient examination glove
510(k) Number K111328
Device Name POWDER FREE NITRILE EXAMINATION GLOVES
Applicant
GX CORPORATION SDN BHD
LOT 6487, BATU 5 3/4, SEMENTA
JALAN KAPAR
KLANG, SELANGOR,  MY 42100
Applicant Contact GANESAN SUPIRAMUNIAM
Correspondent
GX CORPORATION SDN BHD
LOT 6487, BATU 5 3/4, SEMENTA
JALAN KAPAR
KLANG, SELANGOR,  MY 42100
Correspondent Contact GANESAN SUPIRAMUNIAM
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/11/2011
Decision Date 07/15/2011
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
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