REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)

Latex Patient Examination Glove

LONDON INTERNATIONAL GROUP, INC.

The following data is part of a premarket notification filed by London International Group, Inc. with the FDA for Regent Skindende Exam Glove, Regent Biogel D, Regentbiogel Diagnostic (powderfree).

Pre-market Notification Details

Device IDK991677
510k NumberK991677
Device Name:REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
ClassificationLatex Patient Examination Glove
Applicant LONDON INTERNATIONAL GROUP, INC. P.O. BOX 8308 2926 COLUMBIA HIGHWAY Dothan,  AL  36304
ContactBradley L Pugh
CorrespondentBradley L Pugh
LONDON INTERNATIONAL GROUP, INC. P.O. BOX 8308 2926 COLUMBIA HIGHWAY Dothan,  AL  36304
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-17
Decision Date2000-04-12

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