Clearance Summary
LOVE GUARD MALE LATEX CONDOM received FDA 510(k) clearance under submission number K080833, sponsored by Tianjin Human-Care Latex Corporation. 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 2008-08-07.
- Submission: K080833
- Applicant / Sponsor: Tianjin Human-Care Latex Corporation
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2008-08-07
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.