The following data is part of a premarket notification filed by Xiantao Zhibo Nonwoven Products Co., Ltd with the FDA for Disposable Medical Face Mask.
| Device ID | K213806 |
| 510k Number | K213806 |
| Device Name: | Disposable Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Xiantao Zhibo Nonwoven Products Co., Ltd NO.8 In Hefen Industrial Zone, Pengchang Town Xiantao, CN |
| Contact | Fen Peng |
| Correspondent | Jarvis Wu Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Ave. Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-03-12 |