Clearance Summary
Male Latex Condoms received FDA 510(k) clearance under submission number K222611, sponsored by Suzhou Colour-Way New Material 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 2022-11-28.
- Submission: K222611
- Applicant / Sponsor: Suzhou Colour-Way New Material Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2022-11-28
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.