K232279
- 510(k) number
- K232279
- Device name
- LifeStyles NRL Textured Condom
- Applicant
- Suretex Limited TH
- Product code
- HIS — Condom
- Decision date
- 2023-10-05
- Date received
- 2023-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K232279.pdf
Official FDA record: K232279
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.