Clearance Summary
LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) received FDA 510(k) clearance under submission number K942858, sponsored by Suretex, Ltd.. 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 1995-05-18.
- Submission: K942858
- Applicant / Sponsor: Suretex, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1995-05-18
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.