TAN CHONG GLOVE, 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 Tan Chong Glove, Hypoallergenic.

Pre-market Notification Details

Device IDK911146
510k NumberK911146
Device Name:TAN CHONG GLOVE, 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 Received1991-03-07
Decision Date1991-04-18

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