Clearance Summary
Polyisoprene Extra Large Condom received FDA 510(k) clearance under submission number K232470, sponsored by Suretex Limited. 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 2024-05-09.
- Submission: K232470
- Applicant / Sponsor: Suretex Limited
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2024-05-09
Classification & Regulation
This clearance is catalogued under FDA product code MOL and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.