510(k) K260407 ยท FYA Gown, Surgical
Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
| Applicant | Principle & Will Co., Ltd., Apia, WS |
| Decision | Substantially Equivalent, Aug 26, 2026 |
| Received | Feb 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260407
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.