510(k) K261115 · QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
VR® Personal Protective Level 4 Gown (VR Gowns)
| Applicant | PolyConversions, Inc., Champaign IL, US |
| Decision | Substantially Equivalent, Aug 11, 2026 |
| Received | Apr 3, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261115
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.