ONE Male Condom
FDA 510(k) clearance DEN210034 · decided 2022-02-23
Clearance details
- K-number
- DEN210034
- Device name
- ONE Male Condom
- Applicant
- Global Protection Corp.
- Decision
- Unknown
- Date received
- 2021-08-26
- Decision date
- 2022-02-23
- Days to decision
- 181 days
- Clearance type
- Direct
- Product code
- QRZ
- Device class
- 2
- Regulation number
- 884.5305
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.