LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M

Latex Patient Examination Glove

HARTALEGA SDN BHD

The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Latex Powder Free Examination Gloves With Colloidal Oatmeal Usp Skin Protectant Drug With Protein Labeling Claim Of 50 M.

Pre-market Notification Details

Device IDK133953
510k NumberK133953
Device Name:LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
ClassificationLatex Patient Examination Glove
Applicant HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, Selangor,  MY 45600
ContactNurul Aisyah Kong Bt Abdullah
CorrespondentNurul Aisyah Kong Bt Abdullah
HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, Selangor,  MY 45600
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-23
Decision Date2014-05-28

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