510(k) K260310 ยท QSO Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
| Applicant | O&M Halyard, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Oct 28, 2026 |
| Received | Jan 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260310
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.