Medical Device Manufacturer · CA , Concord, Ontario

Hardcover Products, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1999

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hardcover Products, Inc. Obstetrics & Gynecology ✕

2 devices

1-2 of 2

Cleared Jun 18, 1999

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

Obstetrics & Gynecology · 80d

Cleared Jun 17, 1999

MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)

Obstetrics & Gynecology · 90d

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 28, 2026