NITRILE POWDER FREE EXAMINATION GLOVES

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 Gloves.

Pre-market Notification Details

Device IDK110758
510k NumberK110758
Device Name:NITRILE POWDER FREE EXAMINATION GLOVES
ClassificationPolymer 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 CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-18
Decision Date2011-08-12

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