K220550 is an FDA 510(k) clearance for the Disposable Surgical Face Mask (M663BE, M663BT). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Makrite Industries, Inc. (New Taipei, TW). The FDA issued a Cleared decision on June 14, 2022, 109 days after receiving the submission on February 25, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K220550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2022 |
| Decision Date | June 14, 2022 |
| Days to Decision | 109 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 |