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FDA 510(k)

TROJAN Fire & Ice lubricated male natural rubber latex condom

K-Number: K221906 · 2022-09-28

ApplicantChurch & Dwight Co., Inc.
Decision Date2022-09-28
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROJAN Fire & Ice lubricated male natural rubber latex condom is the device name listed in this FDA 510(k) record. The listed applicant is Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K221906. 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 TROJAN Fire & Ice lubricated male natural rubber latex condom?

TROJAN Fire & Ice lubricated male natural rubber latex condom is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K221906.

When did TROJAN Fire & Ice lubricated male natural rubber latex condom receive FDA 510(k) clearance?

TROJAN Fire & Ice lubricated male natural rubber latex condom received FDA 510(k) clearance on 2022-09-28, under 510(k) number K221906.

Who is the listed applicant for TROJAN Fire & Ice lubricated male natural rubber latex condom?

The FDA 510(k) record lists Church & Dwight Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TROJAN Fire & Ice lubricated male natural rubber latex condom?

The FDA product code for TROJAN Fire & Ice lubricated male natural rubber latex condom is HIS.

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Other records listing Church & Dwight Co., Inc. as applicant

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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.

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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