510(k) K160339 ยท FYC Gown, Isolation, Surgical
Cardinal Health Isolation Gown
| Applicant | Cardinal Health200, LLC, Waukegan IL, US |
| Decision | Substantially Equivalent, Jul 28, 2016 |
| Received | Feb 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160339
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2024 | Cardinal Health 200, LLC Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL Open, Classified |
FYC | None listed |
| Dec 11, 2024 | Cardinal Health 200, LLC Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL Open, Classified |
FYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.