MSC
7 FDA 510(k) clearances · Product code
234 daysmedian time to decision
328 days90th percentile
7clearances measured
FDA profile
- Official device name
- Barrier, Std, Oral Sex
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIXI (LXOSFM1) (K253662) | Luwi, LLC | 2026-07-14 |
| Lorals (K212928) | Brazen Goods Inc. Dba Lorals | 2022-04-22 |
| SancDam Latex Oral Dam (K212037) | Sanctuary Health Sdn. Bhd. | 2022-03-28 |
| Harmony Latex Dam, Harmony Non-Latex Dam (K203727) | Pamco Distributing, Inc. | 2021-08-05 |
| TRUST DAM (K091769) | Line One Laboratories, Inc. | 2010-02-05 |
| SHEER GLYDE DAMS (K990067) | Louise C. Myers | 1999-02-19 |
| GLYDE DAM LOLLYES (K970577) | Glyde USA, Inc. | 1998-01-08 |
Track MSC automatically
Every clearance here is in the API, with alerts when new ones post.