MSC — Barrier, Std, Oral Sex Class II
FDA product code MSC covers "Barrier, Std, Oral Sex", a Class II medical device regulated under 21 CFR 884.5300. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MSC
- Device Class
- Class II
- Regulation Number
- 884.5300
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253662 | Luwi | LIXI (LXOSFM1) | Jul 14, 2026 |
| K212928 | Brazen Goods Inc. Dba Lorals | Lorals | Apr 22, 2022 |
| K212037 | Sanctuary Health Sdn. Bhd | SancDam Latex Oral Dam | Mar 28, 2022 |
| K203727 | Pamco Distributing | Harmony Latex Dam, Harmony Non-Latex Dam | Aug 5, 2021 |
| K091769 | Line One Laboratories | TRUST DAM | Feb 5, 2010 |
| K990067 | Louise C. Myers | SHEER GLYDE DAMS | Feb 19, 1999 |
| K970577 | Glyde Usa | GLYDE DAM LOLLYES | Jan 8, 1998 |