Panels › Obstetrics/Gynecology › Product code MSC · Class 2
Barrier, Std, Oral Sex
Regulation 884.5300
1510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MSC
| Company | 510(k)s | Recalls |
|---|---|---|
| Brazen Goods Inc. Dba Lorals | 1 | 0 |
| Glyde USA, Inc. | 1 | 0 |
| Line One Laboratories, Inc. | 1 | 0 |
| Louise C. Myers | 1 | 0 |
| Luwi, LLC | 1 | 0 |
| Pamco Distributing, Inc. | 1 | 0 |
| Sanctuary Health Sdn. Bhd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 2026 | K253662 | LIXI (LXOSFM1) Luwi, LLC | MSC |
| Apr 22, 2022 | K212928 | Lorals Brazen Goods Inc. Dba Lorals | MSC |
| Mar 28, 2022 | K212037 | SancDam Latex Oral Dam Sanctuary Health Sdn. Bhd., MY | MSC |
| Aug 5, 2021 | K203727 | Harmony Latex Dam, Harmony Non-Latex Dam Pamco Distributing, Inc., CA | MSC |
| Feb 5, 2010 | K091769 | TRUST DAM Line One Laboratories, Inc. | MSC |
| Feb 19, 1999 | K990067 | SHEER GLYDE DAMS Louise C. Myers | MSC |
| Jan 8, 1998 | K970577 | GLYDE DAM LOLLYES Glyde USA, Inc. | MSC |
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