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FDA 510(k)

Natural rubber latex male condom

K-Number: K250034 · 2025-07-11

ApplicantShaoguan Regenex Pharmaceuticals Co., Ltd.
Decision Date2025-07-11
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Natural rubber latex male condom is the device name listed in this FDA 510(k) record. The listed applicant is Shaoguan Regenex Pharmaceuticals Co., Ltd.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K250034. 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 Natural rubber latex male condom?

Natural rubber latex male condom is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Shaoguan Regenex Pharmaceuticals Co., Ltd.. The 510(k) number is K250034.

When did Natural rubber latex male condom receive FDA 510(k) clearance?

Natural rubber latex male condom received FDA 510(k) clearance on 2025-07-11, under 510(k) number K250034.

Who is the listed applicant for Natural rubber latex male condom?

The FDA 510(k) record lists Shaoguan Regenex Pharmaceuticals Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Natural rubber latex male condom?

The FDA product code for Natural rubber latex male 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

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 LimitedK243421Lelo 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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