Clearance Summary
Skyn Original Polyisoprene Lubricated Male Condom - Flavored received FDA 510(k) clearance under submission number K171172, sponsored by Ansell Healthcare Products, LLC. 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 2017-08-02.
- Submission: K171172
- Applicant / Sponsor: Ansell Healthcare Products, LLC
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2017-08-02
Classification & Regulation
This clearance is catalogued under FDA product code MOL and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.