510(k) K253003 ยท FYA Gown, Surgical
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)
| Applicant | Hubei Xinxin Non-Woven Co., Ltd., Xiantao, CN |
| Decision | Substantially Equivalent, Apr 20, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253003
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.