Clearance Summary
Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant received FDA 510(k) clearance under submission number K161545, sponsored by Church & Dwight Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2016-08-26.
- Submission: K161545
- Applicant / Sponsor: Church & Dwight Co., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2016-08-26
Classification & Regulation
This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.