Product code OBY
- Device name
- Condom, Female, Animal Tissue
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 3
- Regulation number
- 884.5330
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset