Male Latex Condom
K-Number: K203536 · 2021-09-03
ApplicantGlobal Protection Corp.
Decision Date2021-09-03
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Male Latex Condom is a medical device manufactured by Global Protection Corp.. It received FDA 510(k) clearance on 2021-09-03 under approval number K203536. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Male Latex Condom?
Male Latex Condom is a medical device that received FDA 510(k) clearance on 2021-09-03. It is manufactured by Global Protection Corp.. The 510(k) number is K203536.
When was Male Latex Condom approved by the FDA?
Male Latex Condom received FDA 510(k) clearance on 2021-09-03, under approval number K203536.
What company makes Male Latex Condom?
Male Latex Condom is manufactured by Global Protection Corp..
What is the FDA product code for Male Latex Condom?
The FDA product code for Male Latex Condom is HIS.
Other Devices by Global Protection Corp.
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K161195Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)M3 Global Enterprises, LLC
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.