Submission Details
| 510(k) Number | K161545 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 03, 2016 |
| Decision Date | August 26, 2016 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
Aug 2016
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K161545 is an FDA 510(k) clearance for the Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant, a Condom (Class II — Special Controls, product code HIS), submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on August 26, 2016, 84 days after receiving the submission on June 3, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
Device Classification
| Product Code | HIS — Condom |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5300 |
Manufacturer
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