The following data is part of a premarket notification filed by Hubei Xinxin Non-woven Co.,ltd. with the FDA for Surgical Masks.
| Device ID | K212120 |
| 510k Number | K212120 |
| Device Name: | Surgical Masks |
| Classification | Mask, Surgical |
| Applicant | Hubei Xinxin Non-woven Co.,Ltd. Taizihu Industrial Park, Pengchang Town Xiantao, CN 433018 |
| Contact | Nicole Jin |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-07 |
| Decision Date | 2022-01-28 |