NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)

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 (ablu).

Pre-market Notification Details

Device IDK130473
510k NumberK130473
Device Name:NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya,  MY 45600
ContactNurul Aisyah Kong Bt Abdullah
CorrespondentNurul Aisyah Kong Bt Abdullah
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 Received2013-02-22
Decision Date2013-07-05

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