K203376 is an FDA 510(k) clearance for the ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Medtecs (Taiwan) Corp. (Taipei City, TW). The FDA issued a Cleared decision on March 2, 2022, 470 days after receiving the submission on November 17, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2020 |
| Decision Date | March 02, 2022 |
| Days to Decision | 470 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 |