Clearance Summary
LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 received FDA 510(k) clearance under submission number K024324, sponsored by Global Protection Corp.. 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 2003-03-25.
- Submission: K024324
- Applicant / Sponsor: Global Protection Corp.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2003-03-25
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.