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FDA 510(k)

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant

K-Number: K161545 · 2016-08-26

ApplicantChurch & Dwight Co., Inc.
Decision Date2016-08-26
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is a medical device manufactured by Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2016-08-26 under approval number K161545. 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 XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is a medical device that received FDA 510(k) clearance on 2016-08-26. It is manufactured by Church & Dwight Co., Inc.. The 510(k) number is K161545.

When was Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant approved by the FDA?

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant received FDA 510(k) clearance on 2016-08-26, under approval number K161545.

What company makes Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is manufactured by Church & Dwight Co., Inc..

What is the FDA product code for Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

The FDA product code for Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is HIS.

Other Devices by Church & Dwight Co., Inc.

K161915Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant K161544Trojan Chain Reaction Personal Lubricant K171639Trojan Supra Lubricated Polyurethane Male Condom K180764TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) K180104Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant K193450Pre-Seed™ Fertility Lubricant

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Related Devices (Code: HIS)

K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products , Ltd. K161915Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe LubricantChurch & Dwight Co., Inc. K161195Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)M3 Global Enterprises, LLC K160644Lelo Hex Natural Rubber Latex CondomLelo, Inc. K172414JUD custom fit condomGlobal Mailer Partners, LLC K162919Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd.

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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