K201127 is an FDA 510(k) clearance for the DEFEND Ear-loop Face Masks. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on April 14, 2021, 351 days after receiving the submission on April 28, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2020 |
| Decision Date | April 14, 2021 |
| Days to Decision | 351 days |
| Submission Type | Abbreviated |
| 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 |