ONE Nitrile Condom
FDA 510(k) clearance K240896 · decided 2024-08-23
Clearance details
- K-number
- K240896
- Device name
- ONE Nitrile Condom
- Applicant
- Global Protection Corp.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-01
- Decision date
- 2024-08-23
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- MOL
- Device class
- 2
- Regulation number
- 884.5300
- 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.