The following data is part of a premarket notification filed by Zhejiang Lanhine Medical Products Ltd with the FDA for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask.
| Device ID | K211832 |
| 510k Number | K211832 |
| Device Name: | Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Zhejiang Lanhine Medical Products LTD 1989 Cidong Road, Cidongbinhai District Cixi, CN 315300 |
| Contact | Jerry Gu |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue 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 | 2021-06-14 |
| Decision Date | 2021-09-08 |