SancDam Latex Oral Dam
FDA 510(k) clearance K212037 · decided 2022-03-28
Clearance details
- K-number
- K212037
- Device name
- SancDam Latex Oral Dam
- Applicant
- Sanctuary Health Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-30
- Decision date
- 2022-03-28
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- MSC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chemor, MY
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIXI (LXOSFM1) (K253662) | Luwi, LLC | 2026-07-14 |
| Lorals (K212928) | Brazen Goods Inc. Dba Lorals | 2022-04-22 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.