EASY TOUCH LATEX EAM GLOVES

Latex Patient Examination Glove

SIMPEX, INC.

The following data is part of a premarket notification filed by Simpex, Inc. with the FDA for Easy Touch Latex Eam Gloves.

Pre-market Notification Details

Device IDK920174
510k NumberK920174
Device Name:EASY TOUCH LATEX EAM GLOVES
ClassificationLatex Patient Examination Glove
Applicant SIMPEX, INC. 801 OLD YORK RD. SUITE 318 Jenkintown,  PA  19046
ContactXi Mei
CorrespondentXi Mei
SIMPEX, INC. 801 OLD YORK RD. SUITE 318 Jenkintown,  PA  19046
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-14
Decision Date1992-04-22

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