Clearance Summary
Natural rubber latex male condom received FDA 510(k) clearance under submission number K250034, sponsored by Shaoguan Regenex Pharmaceuticals Co., 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 2025-07-11.
- Submission: K250034
- Applicant / Sponsor: Shaoguan Regenex Pharmaceuticals Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2025-07-11
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.