510(k) K170762 ยท FYA Gown, Surgical
Cardinal Health Non-Reinforced Surgical Gown
| Applicant | Cardinal Health200, LLC, Waukegan IL, US |
| Decision | Substantially Equivalent, Jun 9, 2017 |
| Received | Mar 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170762
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 Terminated |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.