K210970 is an FDA 510(k) clearance for the Single-Use Surgical Mask Model FE2311B. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Byd Precison Manufacturer Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 21, 2021, 112 days after receiving the submission on March 31, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210970 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2021 |
| Decision Date | July 21, 2021 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |