K202240 is an FDA 510(k) clearance for the Disposable Surgical Mask/Fluid Resistant Procedure Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Lhm Medical Technology (Hong Kong) Limited (Hongkong, CN). The FDA issued a Cleared decision on February 25, 2021, 199 days after receiving the submission on August 10, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2020 |
| Decision Date | February 25, 2021 |
| Days to Decision | 199 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 |