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FDA 510(k)

JUD custom fit condom

K-Number: K172414 · 2017-10-12

ApplicantGlobal Mailer Partners, LLC
Decision Date2017-10-12
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

JUD custom fit condom is the device name listed in this FDA 510(k) record. The listed applicant is Global Mailer Partners, LLC. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K172414. 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 JUD custom fit condom?

JUD custom fit condom is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Global Mailer Partners, LLC. The 510(k) number is K172414.

When did JUD custom fit condom receive FDA 510(k) clearance?

JUD custom fit condom received FDA 510(k) clearance on 2017-10-12, under 510(k) number K172414.

Who is the listed applicant for JUD custom fit condom?

The FDA 510(k) record lists Global Mailer Partners, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JUD custom fit condom?

The FDA product code for JUD custom fit condom is HIS.

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

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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