510(k) K103406 ยท FYA Gown, Surgical
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
| Applicant | Kimberly-Clark Corp., Roswell GA, US |
| Decision | Substantially Equivalent, Dec 23, 2010 |
| Received | Nov 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2012 | Kimberly-Clark Corporation ULTRA Fabric Reinforced surgical Gown X-Large Sterile
The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of micro Terminated |
KKX | None listed |
| Nov 7, 2012 | Kimberly-Clark Corporation MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile
The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer Terminated |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.