K201421 is an FDA 510(k) clearance for the Dukal Corporation Level 2 Surgical Mask with Ear Loops. 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 5, 2021, 252 days after receiving the submission on May 29, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2020 |
| Decision Date | February 05, 2021 |
| Days to Decision | 252 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 |