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FDA 510(k)

Male Latex Condoms

K-Number: K162919 · 2017-03-07

ApplicantZhejiang Xiangban Latex Products Co., Ltd.
Decision Date2017-03-07
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 Zhejiang Xiangban Latex Products Co., Ltd.. It received FDA 510(k) clearance on 2017-03-07 under 510(k) number K162919. 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 2017-03-07. The listed applicant is Zhejiang Xiangban Latex Products Co., Ltd.. The 510(k) number is K162919.

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

Male Latex Condoms received FDA 510(k) clearance on 2017-03-07, under 510(k) number K162919.

Who is the listed applicant for Male Latex Condoms?

The FDA 510(k) record lists Zhejiang Xiangban Latex Products 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

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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