The following data is part of a premarket notification filed by Chongqing Litai Fashion Group Limited Company with the FDA for Disposable Surgical Gowns.
| Device ID | K210785 |
| 510k Number | K210785 |
| Device Name: | Disposable Surgical Gowns |
| Classification | Gown, Isolation, Surgical |
| Applicant | Chongqing Litai Fashion Group Limited Company Building D7-1, Chongqing China Textile & Garment City Project, Maliu Yanjiang Development Zone, Chongqing, CN |
| Contact | David Ni |
| Correspondent | Eva Li Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, CN 200122 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-16 |
| Decision Date | 2021-11-13 |