Clearance Summary
aoni Natural Rubber Latex Condom received FDA 510(k) clearance under submission number K153016, sponsored by Guangzhou Daming United Rubber Products , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2016-10-20.
- Submission: K153016
- Applicant / Sponsor: Guangzhou Daming United Rubber Products , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2016-10-20
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.