K252830 is an FDA 510(k) clearance for the Disposable Surgical Face Mask (3P00B, C2900). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Beatles Medical Supplies (Xiantao) Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on January 12, 2026, 129 days after receiving the submission on September 5, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K252830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2025 |
| Decision Date | January 12, 2026 |
| Days to Decision | 129 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 |