Natural rubber latex male condom— 510(k) K250034
Substantially EquivalentShaoguan Regenex Pharmaceuticals Co., Ltd.
FDA 510(k) clearance K250034 for Natural rubber latex male condom, Substantially Equivalent on 2025-07-11. Applicant: Shaoguan Regenex Pharmaceuticals Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shaoguan Regenex Pharmaceuticals Co., Ltd.
- Product code
- Product code HIS
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shaoguan, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.