K252534 is an FDA 510(k) clearance for the Surgical Face Mask (Ear mount). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Zhejiang Hangkang Medical Equipment Co., Ltd. (Yiwu, CN). The FDA issued a Cleared decision on March 3, 2026, 203 days after receiving the submission on August 12, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K252534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2025 |
| Decision Date | March 03, 2026 |
| Days to Decision | 203 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 |