NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE

Polymer Patient Examination Glove

HARTALEGA SDN BHD

The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Free Examination Glove With Colloidal Oatmeal Usp Skin Protectant Drug - Dkbu /dark Blue.

Pre-market Notification Details

Device IDK140050
510k NumberK140050
Device Name:NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya,  MY 45600
ContactNurul Aishyah Kong
CorrespondentNurul Aishyah Kong
HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya,  MY 45600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-09
Decision Date2014-09-12

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