BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC

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 Boston(r) Brand Latex Exam Gloves/hypoallergenic.

Pre-market Notification Details

Device IDK904232
510k NumberK904232
Device Name:BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC
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 Received1990-09-12
Decision Date1990-09-21

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