Male Latex Condom

Condom

Global Protection Corp.

The following data is part of a premarket notification filed by Global Protection Corp. with the FDA for Male Latex Condom.

Pre-market Notification Details

Device IDK203536
510k NumberK203536
Device Name:Male Latex Condom
ClassificationCondom
Applicant Global Protection Corp. 12 Channel Street Boston,  MA  02210
ContactChristina Cataldo
CorrespondentChristina Cataldo
Global Protection Corp. 12 Channel Street Boston,  MA  02210
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-03
Decision Date2021-09-03

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