K252521
- 510(k) number
- K252521
- Device name
- LifeStyles® HydraFeel Natural Rubber Latex Condom
- Applicant
- Suretex Limited TH
- Product code
- HIS — Condom
- Decision date
- 2025-11-18
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252521.pdf
Official FDA record: K252521
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.