LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

REGULUS INTL. CORP.

The following data is part of a premarket notification filed by Regulus Intl. Corp. with the FDA for Latex Examination Gloves.

Pre-market Notification Details

Device IDK893268
510k NumberK893268
Device Name:LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant REGULUS INTL. CORP. 230 PARK AVE. New York,  NY  10169
ContactLee Miller
CorrespondentLee Miller
REGULUS INTL. CORP. 230 PARK AVE. New York,  NY  10169
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-17
Decision Date1989-06-19

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