OBY
- Product code
- OBY
- Device name
- Condom, Female, Animal Tissue
- Device class
- Class 3
- 21 CFR
- 21 CFR 884.5330
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- PMA
FDA classification definition
A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.
Official FDA classification page: OBY
Classification and pathway per current FDA publications. Data from openFDA (CC0).