K212109 is an FDA 510(k) clearance for the Spin Care Disposable Protective Mask Level 3. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Spintech, LLC (Statesville, US). The FDA issued a Cleared decision on November 14, 2021, 131 days after receiving the submission on July 6, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2021 |
| Decision Date | November 14, 2021 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |