K212037 is an FDA 510(k) clearance for the SancDam Latex Oral Dam. This device is classified as a Barrier, Std, Oral Sex (Class II - Special Controls, product code MSC).
Submitted by Sanctuary Health Sdn. Bhd. (Chemor, MY). The FDA issued a Cleared decision on March 28, 2022, 271 days after receiving the submission on June 30, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K212037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2021 |
| Decision Date | March 28, 2022 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MSC - Barrier, Std, Oral Sex |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |