LATEX EXAMINATION GLOVES NON-STERILE

Latex Patient Examination Glove

QUEST INTL., INC.

The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Latex Examination Gloves Non-sterile.

Pre-market Notification Details

Device IDK890356
510k NumberK890356
Device Name:LATEX EXAMINATION GLOVES NON-STERILE
ClassificationLatex Patient Examination Glove
Applicant QUEST INTL., INC. SUITE G, EXECUTIVE PARK CENTRE 6901 SOUTH DALLAS Fort Smith,  AR  72903
ContactJoseph F Kearney
CorrespondentJoseph F Kearney
QUEST INTL., INC. SUITE G, EXECUTIVE PARK CENTRE 6901 SOUTH DALLAS Fort Smith,  AR  72903
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-24
Decision Date1989-04-06

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