510(k) K971920 ยท FYA Gown, Surgical
GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
| Applicant | Customed, Inc., Fajardo PR, US |
| Decision | Substantially Equivalent, Dec 4, 1997 |
| Received | May 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971920
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2016 | Customed, Inc Catalog Number: 9003190
SURG GOWN SMS AMMI IV FULL
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900521
SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE
Used by medical staff to perform surgical procedures and patient care procedures such as wound healin Terminated |
FYA | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900522
SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, Terminated |
FYA | None listed |
| Sep 3, 2015 | Customed, Inc Gown, surgical 30/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
FYA | None listed |
| Sep 3, 2015 | Customed, Inc GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
FYA | None listed |
| Sep 3, 2015 | Customed, Inc GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
HRX | None listed |
| Sep 3, 2015 | Customed, Inc GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
FYA | None listed |
| Sep 3, 2015 | Customed, Inc GOWN IMPERVIOUS EXTRA LONG 24/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc GOWN POLYREINF XLGE TOWEL/W 24/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
FYA | None listed |
| Sep 3, 2015 | Customed, Inc SURG GOWN POLYREINF LGE CUSTOM 28/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.