K201732 is an FDA 510(k) clearance for the Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on February 16, 2021, 236 days after receiving the submission on June 25, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2020 |
| Decision Date | February 16, 2021 |
| Days to Decision | 236 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 |