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

DateFirm and productCodeLinked 510(k)
May 7, 2026Medline Industries, LP
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
Open, Classified
FYANone listed
May 7, 2026Medline Industries, LP
See complete list in RES, exceeds character limit. Medline Surgical Gowns
Open, Classified
FYAK190950
Mar 12, 2026Medline Industries, LP
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL
Open, Classified
FYAK982694
Feb 17, 2026Medline Industries, LP
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002;
Open, Classified
FYAK190950
Dec 11, 2025Cardinal Health 200, LLC
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium
Open, Classified
FYAK193327
Jan 11, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Open, Classified
FYAK182172
Dec 6, 2022Owens & Minor Distribution, Inc.
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Open, Classified
FYAK192362
Nov 16, 2022Texas Medical Technology Inc.
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Open, Classified
FYAK120192
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Open, Classified
FYAK020593
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Open, Classified
FYAK020593
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Open, Classified
FYAK020593
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Open, Classified
FYAK020593
Nov 2, 2021Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Open, Classified
FYAK020593
Nov 2, 2021Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Open, Classified
FYAK020593
Nov 2, 2021Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Open, Classified
FYAK020593
Nov 2, 2021Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Open, Classified
FYAK023167
Nov 2, 2021Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Open, Classified
FYAK023167
Nov 2, 2021Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Open, Classified
FYAK023167
Nov 2, 2021Cardinal Health
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Open, Classified
FYAK150151
Sep 17, 2020THREAD COUNSEL INC DBA LAWS OF MOTION
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
Open, Classified
FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
ROYALSILK XLARGE, Gown. Item Code 9548
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
ROYALSILK 2XLARGE, Gown. Item Code 9578
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
ROYALSILK LARGE, Gown. Item Code 9518
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
Terminated
FYAK061308
Jan 24, 2020Cardinal Health
AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N
Terminated
FYAK170762
Jan 24, 2020Cardinal Health
ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Terminated
FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
Terminated
FYAK020593

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