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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Okamoto USA, Inc.. It received FDA 510(k) clearance on 2025-02-18 under 510(k) 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. The listed applicant is Okamoto USA, Inc.. The 510(k) number is K243584.

When did 0.04 ZERO ZERO FOUR Male Latex Condom receive FDA 510(k) clearance?

0.04 ZERO ZERO FOUR Male Latex Condom received FDA 510(k) clearance on 2025-02-18, under 510(k) number K243584.

Who is the listed applicant for 0.04 ZERO ZERO FOUR Male Latex Condom?

The FDA 510(k) record lists Okamoto USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06557499A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.COMPLETED

Other records listing Okamoto USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252622Male Latex Condom HAK203541Okamoto 002 Lubricated Polyurethane Male CondomK192669Extremely Thin 003, ZERO ZERO THREE

Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.K232279LifeStyles NRL Textured CondomSuretex Limited

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.

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