K232470
- 510(k) number
- K232470
- Device name
- Polyisoprene Extra Large Condom
- Applicant
- Suretex Limited TH
- Product code
- MOL — Condom, Synthetic
- Decision date
- 2024-05-09
- Date received
- 2023-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232470.pdf
Official FDA record: K232470
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.