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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 K151528
Device Name Powder Free Nitrile (Black) Examination Gloves
Applicant
GALLANT QUALITY SDN. BHD.
LOT 1874, JALAN KAMPUNG DEW
TAIPING,  MY 34700
Applicant Contact SUMATHI SARAVANA SAMI
Correspondent
GALLANT QUALITY SDN. BHD.
LOT 1874, JALAN KAMPUNG DEW
TAIPING,  MY 34700
Correspondent Contact SUMATHI SARAVANA SAMI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/08/2015
Decision Date 10/09/2015
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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