QRZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- External Condom For Anal Intercourse Or Vaginal Intercourse
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5305
- Medical specialty
- Obstetrics/Gynecology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ONE Male Condom (DEN210034) | Global Protection Corp. | 2022-02-23 |
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Every clearance here is in the API, with alerts when new ones post.