Clearance Summary
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) received FDA 510(k) clearance under submission number K991047, sponsored by Hardcover Products, Inc.. 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 1999-06-18.
- Submission: K991047
- Applicant / Sponsor: Hardcover Products, Inc.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5310
- Decision date: 1999-06-18
Classification & Regulation
This clearance is catalogued under FDA product code LTZ and 21 CFR 884.5310, within the Obstetrics/Gynecology review panel as a Class II device.