510(k) K091357 ยท FYA Gown, Surgical
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
| Applicant | Kimberly-Clark Corp., Roswell GA, US |
| Decision | Substantially Equivalent, Aug 10, 2009 |
| Received | May 8, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K091357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2012 | Kimberly-Clark Corporation MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras.
The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn Terminated |
FYA | None listed |
| Jul 16, 2012 | Kimberly-Clark Corporation MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras.
The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to Terminated |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.