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FDA 510(k)

Trojan Supra Lubricated Polyurethane Male Condom

K-Number: K171639 · 2017-08-01

ApplicantChurch & Dwight Co., Inc.
Decision Date2017-08-01
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Trojan Supra Lubricated Polyurethane Male 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 2017-08-01 under 510(k) number K171639. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trojan Supra Lubricated Polyurethane Male Condom?

Trojan Supra Lubricated Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K171639.

When did Trojan Supra Lubricated Polyurethane Male Condom receive FDA 510(k) clearance?

Trojan Supra Lubricated Polyurethane Male Condom received FDA 510(k) clearance on 2017-08-01, under 510(k) number K171639.

Who is the listed applicant for Trojan Supra Lubricated Polyurethane Male 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 Supra Lubricated Polyurethane Male Condom?

The FDA product code for Trojan Supra Lubricated Polyurethane Male Condom is MOL.

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 Church & Dwight Co., Inc. 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.

K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)K240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantK221906TROJAN Fire & Ice lubricated male natural rubber latex condomK221431TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricantK203818Replens Long-Lasting Vaginal MoisturizerK193450Pre-Seed™ Fertility Lubricant

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Related Devices (Code: MOL)

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.

K252158Sagami Original 002 Polyurethane Male CondomMayer LaboratoriesK243967ONE Nitrile CondomGlobal Protection Corp.K241617Durex Polyisoprene CondomRb Health (Us), LLCK240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.K240896ONE Nitrile CondomGlobal Protection Corp.K232470Polyisoprene Extra Large CondomSuretex Limited

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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