510(k) K250034
K250034 is an FDA 510(k) premarket notification submitted by Shaoguan Regenex Pharmaceuticals Co., Ltd. for the device "Natural rubber latex male condom". The FDA issued a decision of Substantially Equivalent on July 11, 2025. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2025
- Date Received
- January 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type