QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED

Latex Patient Examination Glove

LATEXX PARTNERS BHD.

The following data is part of a premarket notification filed by Latexx Partners Bhd. with the FDA for Qtexx Powder Free Latex Examination Gloves, Polymer Coated.

Pre-market Notification Details

Device IDK991462
510k NumberK991462
Device Name:QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
ClassificationLatex Patient Examination Glove
Applicant LATEXX PARTNERS BHD. PT. 5054, KAMUNTING IND ESTATE P.O. BOX 9 Kamunting, Perak,  MY 34600
ContactChong Eng Lim
CorrespondentChong Eng Lim
LATEXX PARTNERS BHD. PT. 5054, KAMUNTING IND ESTATE P.O. BOX 9 Kamunting, Perak,  MY 34600
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-27
Decision Date1999-05-28
Summary:summary

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