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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 K132006
Device Name STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
Applicant
HARTALEGA SDN BHD
# 7, KAWASAN PERUSAHAAN SURIA
BATANG BERJUNTAI
SELANGOR, DARUL EHSAN,  MY 45600
Applicant Contact NURUL AISYAH KONG
Correspondent
HARTALEGA SDN BHD
# 7, KAWASAN PERUSAHAAN SURIA
BATANG BERJUNTAI
SELANGOR, DARUL EHSAN,  MY 45600
Correspondent Contact NURUL AISYAH KONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/01/2013
Decision Date 11/07/2013
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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