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FDA 510(k)

Male Latex Condom HA

K-Number: K252622 · 2026-05-04

ApplicantOkamoto USA, Inc.
Decision Date2026-05-04
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Male Latex Condom HA 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 2026-05-04 under 510(k) number K252622. 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 HA?

Male Latex Condom HA is a medical device that received FDA 510(k) clearance on 2026-05-04. The listed applicant is Okamoto USA, Inc.. The 510(k) number is K252622.

When did Male Latex Condom HA receive FDA 510(k) clearance?

Male Latex Condom HA received FDA 510(k) clearance on 2026-05-04, under 510(k) number K252622.

Who is the listed applicant for Male Latex Condom HA?

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 Male Latex Condom HA?

The FDA product code for Male Latex Condom HA 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.

K2435840.04 ZERO ZERO FOUR Male Latex CondomK203541Okamoto 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.

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.K2435840.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, 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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