510(k) K240896
K240896 is an FDA 510(k) premarket notification submitted by Global Protection Corp. for the device "ONE Nitrile Condom". The FDA issued a decision of Substantially Equivalent on August 23, 2024. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Global Protection Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2024
- Date Received
- April 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom, Synthetic
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type