The following data is part of a premarket notification filed by Roki Co., Ltd. with the FDA for Roki Surgical Mask.
| Device ID | K214094 |
| 510k Number | K214094 |
| Device Name: | ROKI Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | ROKI Co., Ltd. 2396 Futamata, Futamata-Cho, Tenryu-ku Hamamatsu-shi, JP 431-3314 |
| Contact | Takamasa Murata |
| Correspondent | Fumiaki Kanai MIC International 4-32-16 Ryogoku Sumida-ku, JP |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-28 |
| Decision Date | 2022-02-24 |