The following data is part of a premarket notification filed by The Good Corporation with the FDA for 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 Surg.
| Device ID | K211771 |
| 510k Number | K211771 |
| Device Name: | 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 Surg |
| Classification | Mask, Surgical |
| Applicant | The GOOD Corporation 47-13 Eoso 3-gil, Cheongbuk-eup Pyeongtaek-si, CN 17795 |
| Contact | Hak Rae Lee |
| Correspondent | Mikael Hellstrand K-Bio Solutions 201 South 4th St, Suite 727 San Jose, CA 95112 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-08 |
| Decision Date | 2022-08-24 |