ClearanceBrief
Panels › General, Plastic Surgery › Product code FYA · Class 2

Gown, Surgical

Regulation 878.4040

10510(k)s in 12 months (298 all time)
5recalls in 12 months (129 all time)
106recalls that name a 510(k)
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Top companies in FYA

Company510(k)sRecalls
Cardinal Health, LLC150
Stryker Instruments Div. of Stryker Corporation030
Medline Industries, Inc.164
Customed, Inc.117
Kimberly-Clark Corp.125
Standard Textile Co., Inc.140
Allegiance Healthcare Corp.80
The Sewing Source, Inc.80
The Buckeye Cellulose Corp.70
Baxter Healthcare Corp60
DateFirm and productCodeLinked 510(k)
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
Terminated		 FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
Terminated		 FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Terminated		 FYAK061308
Jan 24, 2020Cardinal Health
AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Terminated		 FYAK061308
Jan 24, 2020Cardinal Health
AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
Terminated		 FYAK061308
Jan 24, 2020Cardinal Health
AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
Terminated		 FYAK061308
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
Terminated		 FYAK061308
Nov 21, 2018American Contract Systems, Inc.
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANG
Terminated		 FYANone listed
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Terminated		 FYAK070078
Feb 23, 2018Stryker Instruments Div. of Stryker Corporation
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Terminated		 FYAK070078
Jun 1, 2017Master & Frank (Pinghu) Co., Ltd.
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
Open, Classified		 FYAK964142
Apr 14, 2016Customed, 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		 FYAK971920
Apr 14, 2016Customed, 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		 FYAK971920
Sep 3, 2015Customed, 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		 FYAK971920
Sep 3, 2015Customed, 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		 FYAK971920
Sep 3, 2015Customed, 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		 FYAK971920
Sep 3, 2015Customed, 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		 FYAK971920
Sep 3, 2015Customed, 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		 FYAK971920
Sep 3, 2015Customed, Inc
LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated		 FYAK902886
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.
Terminated		 FYANone listed
Mar 27, 2015Microtek Medical Inc
FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating
Terminated		 FYAK001082
K910515
Mar 27, 2015Microtek Medical Inc
FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating
Terminated		 FYAK001082
K910515
Mar 27, 2015Microtek Medical Inc
FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment
Terminated		 FYAK001082
K910515
Mar 27, 2015Microtek Medical Inc
FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical pe
Terminated		 FYAK001082
K910515
Feb 10, 2015Stryker Instruments Div. of Stryker Corporation
Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Adva
Terminated		 FYAK073017
Dec 16, 2014Customed, Inc
Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated		 FYANone listed
Dec 16, 2014Customed, Inc
Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated		 FYANone listed
Dec 16, 2014Customed, Inc
Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated		 FYANone listed
Dec 16, 2014Customed, Inc
Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated		 FYANone listed
Dec 16, 2014Customed, Inc
Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated		 FYANone listed
Dec 16, 2014Customed, Inc
Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated		 FYANone listed
Dec 16, 2014Customed, Inc
Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated		 FYANone listed
Dec 16, 2014Customed, Inc
Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated		 FYANone listed
Dec 16, 2014Customed, Inc
Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated		 FYANone listed
Jun 6, 2013Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating
Terminated		 FYAK070078
Jun 6, 2013Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating ro
Terminated		 FYAK070078
Jun 6, 2013Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room
Terminated		 FYAK070078
Jun 6, 2013Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room p
Terminated		 FYAK070078
Jun 6, 2013Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room
Terminated		 FYAK070078

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