K241617
- 510(k) number
- K241617
- Device name
- Durex Polyisoprene Condom
- Applicant
- Rb Health (Us), LLC NJ · US
- Product code
- MOL — Condom, Synthetic
- Decision date
- 2025-02-28
- Date received
- 2024-06-05
- 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: K241617
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.