510(k) K262007 ยท QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
PRIMED AAMI Level 3 Open Back Gowns
| Applicant | PRIMED Medical Products, Inc., Edmonton, CA |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Jun 15, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262007
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.