UniTex Non-Sterile, Powder-Free, Latex Examination Glove

Latex Patient Examination Glove

UG GLOBAL RESOURCES SDN BHD

The following data is part of a premarket notification filed by Ug Global Resources Sdn Bhd with the FDA for Unitex Non-sterile, Powder-free, Latex Examination Glove.

Pre-market Notification Details

Device IDK161961
510k NumberK161961
Device Name:UniTex Non-Sterile, Powder-Free, Latex Examination Glove
ClassificationLatex Patient Examination Glove
Applicant UG GLOBAL RESOURCES SDN BHD Lot 62 & 63, Lorong Senawang 3/2 Kawasan Perindustrian Senawang Seremban,  MY 70450
ContactWong See Keong
CorrespondentKenneth J. Stanton
UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa,  CA  92626
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-18
Decision Date2017-05-11
Summary:summary

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