# Single-Use Internal Condom
> **Product code: MBU** · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5340
## Classification
- **FDA Product Code:** MBU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 884.5340
- **Review panel:** OB
- **Medical specialty:** Obstetrics/Gynecology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=MBU)
---
*AI Analytics · CC0 1.0*