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FDA 510(k)

Male Latex Condoms

K-Number: K222611 · 2022-11-28

ApplicantSuzhou Colour-Way New Material Co., Ltd.
Decision Date2022-11-28
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Male Latex Condoms is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Colour-Way New Material Co., Ltd.. It received FDA 510(k) clearance on 2022-11-28 under 510(k) number K222611. 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 Condoms?

Male Latex Condoms is a medical device that received FDA 510(k) clearance on 2022-11-28. The listed applicant is Suzhou Colour-Way New Material Co., Ltd.. The 510(k) number is K222611.

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

Male Latex Condoms received FDA 510(k) clearance on 2022-11-28, under 510(k) number K222611.

Who is the listed applicant for Male Latex Condoms?

The FDA 510(k) record lists Suzhou Colour-Way New Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Male Latex Condoms?

The FDA product code for Male Latex Condoms 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 Suzhou Colour-Way New Material Co., Ltd. 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.

K240790Polyisoprene Surgical glovesK222620Sterilized Latex Surgical Gloves

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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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