510(k) K261811 ยท QSO Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)
| Applicant | PRIMED Medical Products, Inc., Edmonton, CA |
| Decision | Substantially Equivalent, Sep 1, 2026 |
| Received | Jun 1, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261811
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.