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FDA 510(k)

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

K-Number: K161915 · 2016-09-09

Decision Date2016-09-09
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Trojan XOXO Ribbed 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 2016-09-09 under approval number K161915. 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 Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Church & Dwight Co., Inc.. The 510(k) number is K161915.

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

Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant received FDA 510(k) clearance on 2016-09-09, under approval number K161915.

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

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

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.