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)
Top companies in FYA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2026 | Medline 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 |
FYA | None listed |
| May 7, 2026 | Medline Industries, LP See complete list in RES, exceeds character limit. Medline Surgical Gowns Open, Classified |
FYA | K190950 |
| Mar 12, 2026 | Medline 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 |
FYA | K982694 |
| Feb 17, 2026 | Medline 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 |
FYA | K190950 |
| Dec 11, 2025 | Cardinal 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 |
FYA | K193327 |
| Jan 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile. Open, Classified |
FYA | K182172 |
| Dec 6, 2022 | Owens & Minor Distribution, Inc. Aero Blue Performance Surgical Gown, XL- Sterile surgical gown
Code: 41734 Open, Classified |
FYA | K192362 |
| Nov 16, 2022 | Texas 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 |
FYA | K120192 |
| Nov 2, 2021 | Cardinal Health RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long
SKU: 95998 Open, Classified |
FYA | K020593 |
| Nov 2, 2021 | Cardinal Health RoyalSilk Non-Reinforced Surgical Gowns XX-large
SKU: 9578 Open, Classified |
FYA | K020593 |
| Nov 2, 2021 | Cardinal Health RoyalSilk Non-Reinforced Surgical Gowns X-large
SKU: 9548 Open, Classified |
FYA | K020593 |
| Nov 2, 2021 | Cardinal Health RoyalSilk Non-Reinforced Surgical Gowns Large
SKU: 9518 Open, Classified |
FYA | K020593 |
| Nov 2, 2021 | Cardinal Health Cardinal Health Poly-Reinforced Surgical Gowns XX-large
SKU: 9070 Open, Classified |
FYA | K020593 |
| Nov 2, 2021 | Cardinal Health Cardinal Health Poly-Reinforced Surgical Gowns X-large
SKU: 9040 Open, Classified |
FYA | K020593 |
| Nov 2, 2021 | Cardinal Health Cardinal Health Poly-Reinforced Surgical Gowns Large
SKU: 9010 Open, Classified |
FYA | K020593 |
| Nov 2, 2021 | Cardinal Health SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long
SKU: 9041EL Open, Classified |
FYA | K023167 |
| Nov 2, 2021 | Cardinal Health SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large
SKU: 9041 Open, Classified |
FYA | K023167 |
| Nov 2, 2021 | Cardinal Health SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large
SKU: 9011 Open, Classified |
FYA | K023167 |
| Nov 2, 2021 | Cardinal Health SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line
SKU: 32474 Open, Classified |
FYA | K150151 |
| Sep 17, 2020 | THREAD COUNSEL INC DBA LAWS OF MOTION LOM Disposable Surgical Gowns/Medical Gowns, Single-Use Open, Classified |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health ROYALSILK XLARGE, Gown. Item Code 9548 Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541 Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health ROYALSILK 2XLARGE, Gown. Item Code 9578 Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health ROYALSILK LARGE, Gown. Item Code 9518 Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA Terminated |
FYA | K061308 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N Terminated |
FYA | K170762 |
| Jan 24, 2020 | Cardinal Health ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC Terminated |
FYA | K020593 |
| Jan 24, 2020 | Cardinal Health AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC Terminated |
FYA | K020593 |
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