# Condom, Female, Animal Tissue
> **Product code: OBY** · Class III — High Risk (PMA approval required, life-sustaining) · Obstetrics/Gynecology · 21 CFR 884.5330
## Classification
- **FDA Product Code:** OBY
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 884.5330
- **Review panel:** OB
- **Medical specialty:** Obstetrics/Gynecology
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OBY)
---
*AI Analytics · CC0 1.0*