Clearance Summary
FAMA Male Latex Condoms received FDA 510(k) clearance under submission number K220576, sponsored by Shanghai Personage Hygiene Products 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 2022-08-05.
- Submission: K220576
- Applicant / Sponsor: Shanghai Personage Hygiene Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2022-08-05
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.