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FDA 510(k)

THEYFIT MALE CONDOM

K-Number: K122219 · 2013-09-27

ApplicantTheyfit
Decision Date2013-09-27
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THEYFIT MALE CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Theyfit. It received FDA 510(k) clearance on 2013-09-27 under 510(k) number K122219. 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 THEYFIT MALE CONDOM?

THEYFIT MALE CONDOM is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Theyfit. The 510(k) number is K122219.

When did THEYFIT MALE CONDOM receive FDA 510(k) clearance?

THEYFIT MALE CONDOM received FDA 510(k) clearance on 2013-09-27, under 510(k) number K122219.

Who is the listed applicant for THEYFIT MALE CONDOM?

The FDA 510(k) record lists Theyfit as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THEYFIT MALE CONDOM?

The FDA product code for THEYFIT MALE CONDOM is HIS.

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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.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.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.

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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