DEN210034 is an FDA 510(k) submission for the ONE Male Condom. This device is classified as a External Condom For Anal Intercourse Or Vaginal Intercourse (Class II - Special Controls, product code QRZ).
Submitted by Global Protection Corp. (Boston, US). The FDA issued a Not Cleared (DENG) decision on February 23, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5305. 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..
| 510(k) Number | DEN210034 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 26, 2021 |
| Decision Date | February 23, 2022 |
| Days to Decision | 181 days |
| Submission Type | Direct |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | QRZ - External Condom For Anal Intercourse Or Vaginal Intercourse |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5305 |
| 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. |