Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Skin Protectant And Tested For Use With Chemotherapy Drugs (Dawn 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 And Tested For Use With Chemotherapy Drugs (dawn Blue).

Pre-market Notification Details

Device IDK171874
510k NumberK171874
Device Name:Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Skin Protectant And Tested For Use With Chemotherapy Drugs (Dawn Blue)
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara,  MY 52200
ContactKuan Kam Hon
CorrespondentNurul Aisyah Kong
HARTALEGA SND. 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 Received2017-06-23
Decision Date2017-10-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10850043811296 K171874 000
10850043811289 K171874 000
10850043811272 K171874 000
10850043811265 K171874 000
10850043811258 K171874 000

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