0.04 ZERO ZERO FOUR Male Latex Condom
K-Number: K243584 · 2025-02-18
ApplicantOkamoto USA, Inc.
Decision Date2025-02-18
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
0.04 ZERO ZERO FOUR Male Latex Condom is a medical device manufactured by Okamoto USA, Inc.. It received FDA 510(k) clearance on 2025-02-18 under approval number K243584. 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 0.04 ZERO ZERO FOUR Male Latex Condom?
0.04 ZERO ZERO FOUR Male Latex Condom is a medical device that received FDA 510(k) clearance on 2025-02-18. It is manufactured by Okamoto USA, Inc.. The 510(k) number is K243584.
When was 0.04 ZERO ZERO FOUR Male Latex Condom approved by the FDA?
0.04 ZERO ZERO FOUR Male Latex Condom received FDA 510(k) clearance on 2025-02-18, under approval number K243584.
What company makes 0.04 ZERO ZERO FOUR Male Latex Condom?
0.04 ZERO ZERO FOUR Male Latex Condom is manufactured by Okamoto USA, Inc..
What is the FDA product code for 0.04 ZERO ZERO FOUR Male Latex Condom?
The FDA product code for 0.04 ZERO ZERO FOUR Male Latex Condom is HIS.
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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.