QRZ — External Condom For Anal Intercourse Or Vaginal Intercourse Class II
FDA product code QRZ covers "External Condom For Anal Intercourse Or Vaginal Intercourse", a Class II medical device regulated under 21 CFR 884.5305. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QRZ
- Device Class
- Class II
- Regulation Number
- 884.5305
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210034 | global protection | ONE Male Condom | February 23, 2022 |