K250034
- 510(k) number
- K250034
- Device name
- Natural rubber latex male condom
- Applicant
- Shaoguan Regenex Pharmaceuticals Co., Ltd. CN
- Product code
- HIS — Condom
- Decision date
- 2025-07-11
- Date received
- 2025-01-07
- 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: K250034
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.