QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED

Polymer 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, Non-chlorinated, Powder Free Nitrile Examination Gloves, Polymer-coated.

Pre-market Notification Details

Device IDK992924
510k NumberK992924
Device Name:QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
ClassificationPolymer Patient Examination Glove
Applicant LATEXX PARTNERS BHD. PT. 5054, KAMUNTING IND ESTATE P.O. BOX 9 Kamunting, Perak,  MY 34600
ContactLim Chong Eng
CorrespondentLim Chong Eng
LATEXX PARTNERS BHD. PT. 5054, KAMUNTING IND ESTATE P.O. BOX 9 Kamunting, Perak,  MY 34600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-30
Decision Date1999-11-05
Summary:summary

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