ONE Nitrile Condom
K-Number: K243967 · 2025-04-08
ApplicantGlobal Protection Corp.
Decision Date2025-04-08
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
ONE Nitrile Condom is a medical device manufactured by Global Protection Corp.. It received FDA 510(k) clearance on 2025-04-08 under approval number K243967. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ONE Nitrile Condom?
ONE Nitrile Condom is a medical device that received FDA 510(k) clearance on 2025-04-08. It is manufactured by Global Protection Corp.. The 510(k) number is K243967.
When was ONE Nitrile Condom approved by the FDA?
ONE Nitrile Condom received FDA 510(k) clearance on 2025-04-08, under approval number K243967.
What company makes ONE Nitrile Condom?
ONE Nitrile Condom is manufactured by Global Protection Corp..
What is the FDA product code for ONE Nitrile Condom?
The FDA product code for ONE Nitrile Condom is MOL.
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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.