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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 K130038
Device Name POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
Applicant
HL RUBBER INDUSTRIES SDN BHD
LOT 10, KAWASAN
PERINDUSTRIAN DIOH
KUALA PILAH, NEGERI SEMBILAN,  MY 72000
Applicant Contact NOORZALIZA AHMAD
Correspondent
HL RUBBER INDUSTRIES SDN BHD
LOT 10, KAWASAN
PERINDUSTRIAN DIOH
KUALA PILAH, NEGERI SEMBILAN,  MY 72000
Correspondent Contact NOORZALIZA AHMAD
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received01/07/2013
Decision Date 02/21/2013
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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