The following data is part of a premarket notification filed by Taiwan Comfort Champ Manufacturing Co., Ltd. with the FDA for Surgical Face Mask.
| Device ID | K212863 |
| 510k Number | K212863 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Taiwan Comfort Champ Manufacturing Co., Ltd. No. 55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan City, TW 33068 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min Chinese-European Industrial Research Society No. 58, Fu-Chiun St Hsin-chu City, TW 30067 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-08 |
| Decision Date | 2022-02-19 |