Product code MSC
- Device name
- Barrier, Std, Oral Sex
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5300
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212928 | Lorals | Brazen Goods Inc. Dba Lorals | 2022-04-22 |
| K212037 | SancDam Latex Oral Dam | Sanctuary Health Sdn. Bhd. | 2022-03-28 |
| K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Pamco Distributing, Inc. | 2021-08-05 |
| K091769 | TRUST DAM | Line One Laboratories, Inc. | 2010-02-05 |
| K990067 | SHEER GLYDE DAMS | Louise C. Myers | 1999-02-19 |
| K970577 | GLYDE DAM LOLLYES | Glyde USA, Inc. | 1998-01-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00726893120600 | harmony Non- Latex dams | GLOBAL PROTECTION CORP. | 2026-06-08 |
| 00726893120617 | Harmony Latex Dams | GLOBAL PROTECTION CORP. | 2026-06-08 |
| 00726893120594 | Harmony Latex Dam | GLOBAL PROTECTION CORP. | 2026-06-08 |
| 00726893120587 | Harmony non-Latex Dam | GLOBAL PROTECTION CORP. | 2026-06-04 |
| 09555514012991 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2025-02-13 |
| 29555514012995 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2025-02-13 |
| 00726893118416 | Custom Condoms | GLOBAL PROTECTION CORP. | 2025-01-06 |
| 00726893118324 | LTS Safer Sex Kit | GLOBAL PROTECTION CORP. | 2025-01-06 |
| 00628347062774 | Harmony Polyisoprene Single Sleeve | Pamco Distributing Inc | 2024-05-30 |
| 00628347062736 | Harmony Latex Single Sleeve | Pamco Distributing Inc | 2024-05-30 |
| 19555514011380 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2023-10-20 |
| 19555514001404 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2023-10-20 |
| 19555514001398 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2023-10-20 |
| 09555514001391 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2023-10-20 |
| 09555514001407 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2023-10-20 |
| 09555514011383 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2023-10-20 |
| 09555514011413 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2023-10-20 |
| 09555514011420 | SancDam™ | SANCTUARY HEALTH SDN. BHD. | 2023-10-20 |
| 00726893114913 | Satin Dams | GLOBAL PROTECTION CORP. | 2023-07-07 |
| 00726893115101 | Satin Dams | GLOBAL PROTECTION CORP. | 2023-07-07 |
| 00850049875011 | Lorals | Brazen Goods Inc. | 2023-02-04 |
| 00850049875004 | Lorals | Brazen Goods Inc. | 2023-02-04 |
| 00860008392169 | Lorals | Brazen Goods Inc. | 2022-12-19 |
| 00860008392176 | Lorals | Brazen Goods Inc. | 2022-12-19 |
| 00860008392152 | Lorals | Brazen Goods Inc. | 2022-08-12 |
| 00860008392145 | Lorals | Brazen Goods Inc. | 2022-08-12 |
| 00628347065553 | Harmony Polyisoprene Dams Bulk Box | Pamco Distributing Inc | 2022-02-17 |
| 00628347062729 | Harmony Latex Dam Bulk Box | Pamco Distributing Inc | 2022-02-17 |
| 00628347065881 | Harmony Polyisoprene Dam Retail Pack | Pamco Distributing Inc | 2022-02-17 |
| 00628347069810 | Harmony Latex Dam Retail Pack | Pamco Distributing Inc | 2022-02-17 |