510(k) K193327 ยท FYA Gown, Surgical
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
| Applicant | Cardinal Health200, LLC, Waukegan IL, US |
| Decision | Substantially Equivalent, Mar 20, 2020 |
| Received | Dec 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193327
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | Cardinal Health 200, LLC ChemoPlus gowns:
Product Code Product Description
CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile;
CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Open, Classified |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.