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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 K141021
Device Name POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
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  
Date Received04/21/2014
Decision Date 08/26/2014
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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