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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 K140050
Device Name NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
Applicant
HARTALEGA SDN BHD
NO. 7, KAWASAN PERUSAHAAN
SURIA
BESTARI JAYA,  MY 45600
Applicant Contact NURUL AISHYAH KONG
Correspondent
HARTALEGA SDN BHD
NO. 7, KAWASAN PERUSAHAAN
SURIA
BESTARI JAYA,  MY 45600
Correspondent Contact NURUL AISHYAH KONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/09/2014
Decision Date 09/12/2014
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
Predetermined Change
Control Plan Authorized		 No
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