K211771 is an FDA 510(k) clearance for the The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by The Good Corporation (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on August 24, 2022, 442 days after receiving the submission on June 8, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2021 |
| Decision Date | August 24, 2022 |
| Days to Decision | 442 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 |