Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Tested For Use With Chemotherapy Drugs

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 Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK162819
510k NumberK162819
Device Name:Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Tested For Use With Chemotherapy Drugs
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara,  MY 52200
ContactKuan Kam Hon
CorrespondentNurul Aisyah 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 Received2016-10-06
Decision Date2017-01-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.