Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)

Polymer Patient Examination Glove

HARTALEGA SDB. BHD.

The following data is part of a premarket notification filed by Hartalega Sdb. Bhd. with the FDA for Nitrile Powder Free Examination Glove With Colloidal Oatmeal Usp Skin Protectant Drug- Dark Violet Blue (dvbu).

Pre-market Notification Details

Device IDK142805
510k NumberK142805
Device Name:Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA SDB. BHD. DATARAN SD PJU9 Bandar Sri Damansara,  MY 52200
ContactKuan Kam Hon
CorrespondentNurul Aisyah Kong Bt Abdullah
HARTALEGA SDB. 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 Received2014-09-29
Decision Date2014-12-18

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