K240916 is an FDA 510(k) clearance for the Surgical Face Mask (Tie on/ Ear loops). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Xiantao Daoqi Plastic Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on October 18, 2024, 198 days after receiving the submission on April 3, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K240916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2024 |
| Decision Date | October 18, 2024 |
| Days to Decision | 198 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 |