K240896
- 510(k) number
- K240896
- Device name
- ONE Nitrile Condom
- Applicant
- Global Protection Corp. MA · US
- Product code
- MOL — Condom, Synthetic
- Decision date
- 2024-08-23
- Date received
- 2024-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240896
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.