Xiantao, CN · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FYC | Gown, Isolation, Surgical | Class II | General, Plastic Surgery | 2 | 2022-10-11 |
| FYA | Gown, Surgical | Class II | General, Plastic Surgery | 1 | 2026-04-20 |
| FXX | — | — | — | 1 | 2022-01-28 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-20 | K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | FYA | Class II | General, Plastic Surgery |
| 2022-10-11 | K214116 | AAMI4 Isolation Gown | FYC | Class II | General, Plastic Surgery |
| 2022-05-16 | K213832 | AAMI3 Isolation Gown | FYC | Class II | General, Plastic Surgery |
| 2022-01-28 | K212120 | Surgical Masks | FXX | — | — |