Clearance Summary
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM received FDA 510(k) clearance under submission number K070800, sponsored by Ansell Healthcare Products, LLC. 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 2008-03-06.
- Submission: K070800
- Applicant / Sponsor: Ansell Healthcare Products, LLC
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2008-03-06
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.