K211827 is an FDA 510(k) clearance for the Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Zhejiang Lanhine Medical Products, Ltd. (Cixi, CN). The FDA issued a Cleared decision on September 23, 2021, 101 days after receiving the submission on June 14, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2021 |
| Decision Date | September 23, 2021 |
| Days to Decision | 101 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 |