K240258 is an FDA 510(k) clearance for the Disposable Medical Face Mask (M643BE). 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 April 18, 2024, 78 days after receiving the submission on January 31, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K240258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2024 |
| Decision Date | April 18, 2024 |
| Days to Decision | 78 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 |