POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM

Latex Patient Examination Glove

BOSTON MEDICAL CORP.

The following data is part of a premarket notification filed by Boston Medical Corp. with the FDA for Powder-free Latex Exam Glove W/hypoallergenic Claim.

Pre-market Notification Details

Device IDK960841
510k NumberK960841
Device Name:POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM
ClassificationLatex Patient Examination Glove
Applicant BOSTON MEDICAL CORP. 12011 GUILFORD RD. Annapolis Junction,  MD  20701
ContactTimothy F Hand
CorrespondentTimothy F Hand
BOSTON MEDICAL CORP. 12011 GUILFORD RD. Annapolis Junction,  MD  20701
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-27
Decision Date1996-08-15

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