Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Gown, Surgical

FDA product code FYA · 290 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4040
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-11 – 2026-08-26

FYA 2026-08-26

Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns

Applicant Principle & Will Co., Ltd.

K number K260407

View details →

FYA 2026-08-07

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

Applicant Yadu Medical (Henan) Co., Ltd.

K number K261028

View details →

FYA 2026-07-10

NYES Tuff Cuff L3 Disposable Gowns

Applicant New York Embroidery Studio

K number K261949

View details →

FYA 2026-06-04

Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)

Applicant New York Embroidery Studio (NYES)

K number K252575

View details →

FYA 2026-05-12

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

Applicant Hindernis DE Mexico, S.A.P.I. DE C.V.

K number K260725

View details →

FYA 2026-04-28

Cardinal Health™ Poly Reinforced Surgical Gown

Applicant Cardinal Health 200, LLC

K number K253243

View details →

FYA 2026-04-20

Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K number K253003

View details →

FYA 2026-02-26

Copioumed AAMI 3 Surgical Gown

Applicant Copioumed International, Inc.

K number K251860

View details →

FYA 2026-02-04

Henan Yadu Level 4 Surgical Gowns (Reinforced)

Applicant Yadu Medical (Henan) Co., Ltd.

K number K252301

View details →

FYA 2025-12-03

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

Applicant Yadu Medical (Henan) Co., Ltd.

K number K250564

View details →

FYA 2025-05-30

ViVi® Toga Premium

Applicant Thi Total Healthcare Innovation GmbH

K number K243522

View details →

FYA 2025-05-05

Dream Medi Sterile Surgical Gown (SurgicalGownUL)

Applicant Dae Myung Chemical Co., Ltd. (Vietnam)

K number K242937

View details →

FYA 2025-02-26

Medline Level 4 Surgical Gown with Breathable Sleeves

Applicant Medline Industries, LP

K number K242844

View details →

FYA 2024-10-16

Stryker Steri-Shield 8 Surgical Hoods and Togas

Applicant Stryker Instruments

K number K241272

View details →

FYA 2024-09-10

ProPel SG3™ Surgical Gown

Applicant Standard Textile Co., Inc.

K number K241214

View details →

FYA 2024-08-02

GCI Surgical Gown

Applicant George Courey, Inc.

K number K233571

View details →

FYA 2024-03-29

Disposable Surgical Gown

Applicant Nanning Tecbod Biological Technology Co., Ltd.

K number K233068

View details →

FYA 2024-02-01

Surgical Gown (40083)

Applicant Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.

K number K233183

View details →

FYA 2023-10-12

Skypro, Surgical Gown 6021

Applicant Skypro Medical Supplies Company

K number K230707

View details →

FYA 2023-08-23

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

Applicant Dongguan Shin YI Healthcare Products Factory

K number K230610

View details →

FYA 2023-08-22

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)

Applicant Xiantao Zhibo Non-Woven Products Co., Ltd.

K number K231510

View details →

FYA 2023-08-16

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

Applicant Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi

K number K230577

View details →

FYA 2023-07-27

Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets

Applicant Cardinal Health200, LLC

K number K230838

View details →

FYA 2023-06-16

Surgical Gown

Applicant Hubei Woozon Healthcare Co., Ltd.

K number K222999

View details →

FYA 2023-03-12

High Protection Surgical Gown

Applicant 3A Medical Products Co., Ltd.

K number K222456

View details →

FYA 2023-03-07

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

Applicant Xiamen Probtain Medical Techology Co., Ltd.

K number K223401

View details →

FYA 2023-02-23

Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3

Applicant Stringking

K number K221559

View details →

FYA 2023-02-16

Surgical Gown

Applicant Bayteks Teknik Tekstil San. VE Tic. A.S.

K number K213844

View details →

FYA 2023-02-10

SEJONG Surgical Gown Soft

Applicant Sejong Healthcare Co., Ltd.

K number K220435

View details →

FYA 2023-01-26

Surgical Gown

Applicant Guangzhou Fuzelong Hygiene Material Co., Ltd.

K number K222403

View details →

FYA 2022-12-21

Comfort Gown, Safewear Gown

Applicant Xuchang Zhengde Environstar Medical Products Co., Ltd.

K number K213893

View details →

FYA 2022-11-16

Surgical Gown

Applicant Xianning Marveldas Protective Articles Co., Ltd.

K number K212812

View details →

FYA 2022-11-14

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K number K222480

View details →

FYA 2022-11-10

Bodygard SFS Surgical Gown Level 4

Applicant Feliks Plastik Laminasyon VE Ambalaj Malzemeleri

K number K221139

View details →

FYA 2022-10-28

Disposable Surgical Gown Rk-3011C

Applicant Xiantao Rhycom Non-Woven Products Co., Ltd.

K number K211060

View details →

FYA 2022-10-20

Disposable Surgical Gown (G4003)

Applicant Xiantao Topmed Nonwoven Protective Products Co., Ltd.

K number K221977

View details →

FYA 2022-10-07

YADU Surgical Gowns

Applicant Henan Yadu Industrial Co., Ltd.

K number K220092

View details →

FYA 2022-09-29

Surgical Gown (Sterile); Surgical Gown (Non-sterile)

Applicant Allmed Medical (Hubei) Protective Products Co., Ltd.

K number K221637

View details →

FYA 2022-09-20

Disposable Surgical Gown UM-148

Applicant Unimax Medical Products Co., Ltd.

K number K221717

View details →

FYA 2022-09-19

35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown

Applicant Winner Medical Co., Ltd.

K number K221819

View details →

FYA 2022-07-22

Sterile Level 3 Surgical Gown

Applicant Barco Tekstil Sanayi VE Ticaret A.S.

K number K211399

View details →

FYA 2022-06-03

Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile

Applicant Excellent Medical Technology Group Co., Ltd.

K number K220665

View details →

FYA 2022-05-18

Medline Orbis LVL 3 Surgical Gown

Applicant Medline Industries, LP

K number K220333

View details →

FYA 2022-05-11

Plus Medical Cover Gown

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K number K213177

View details →

FYA 2022-05-06

Medline Orbis Chemo Surgical Gown

Applicant Medline Industries, LP

K number K214108

View details →

FYA 2022-05-04

Plus Medical Chemotherapy Gown

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K number K211036

View details →

FYA 2022-04-12

Disposable Surgical Gown

Applicant Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

K number K214088

View details →

FYA 2022-03-18

Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

Applicant Dukal Corporation

K number K203237

View details →

FYA 2022-03-11

Maxima Surgical Gown

Applicant Elevate Textiles

K number K201351

View details →

FYA 2022-03-04

Surgical Gown

Applicant Wujiang Tutaike Textiles & Finishing Co., Ltd.

K number K213703

View details →

FYA 2022-02-24

Bodygard SFS Surgical Gown Level 3

Applicant Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi

K number K202845

View details →

FYA 2022-02-21

EndoArmor™ + Surgical Gown

Applicant Boston Scientific Corporation

K number K203548

View details →

FYA 2022-01-12

Surgical gowns

Applicant Xiantao Dingcheng Non-Woven Product Co., Ltd.

K number K212718

View details →

FYA 2022-01-11

Disposable Surgical Gown

Applicant Suzhou Janee Medical Technology Co., Ltd.

K number K212591

View details →

FYA 2021-12-16

Surgical Gown, Model: surgical gown-hp-3

Applicant Weihai Dishang Medical Technology Co., Ltd.

K number K210355

View details →

FYA 2021-12-15

Surgical Gown, Reinforced Surgical Gown

Applicant Wuhan Zonsen Medical Products Co., Ltd.

K number K212861

View details →

FYA 2021-12-13

Disposable Surgical Gown

Applicant Henan Robestain Medical Products Co., Ltd.

K number K212925

View details →

FYA 2021-12-13

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

Applicant Fugou County Shenxiang Manufacturing Co., Ltd.

K number K212869

View details →

FYA 2021-12-10

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)

Applicant Unicoglobal, Inc.

K number K203539

View details →

FYA 2021-11-23

Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown

Applicant Cardinal Health, LLC

K number K211765

View details →

FYA 2021-10-24

Surgical Gown

Applicant Hubei Wanli Protective Products Co., Ltd.

K number K211509

View details →

FYA 2021-10-18

Surgical Gown

Applicant Wuhan Dymex Healthcare Co., Ltd.

K number K211809

View details →

FYA 2021-10-07

Surgical Gown

Applicant Wujiang Tutaike Textiles & Finishing Co., Ltd.

K number K211077

View details →

FYA 2021-08-21

Disposable Surgical Gowns

Applicant Anhui Medpurest Medical Technology Co.,Ltd

K number K202532

View details →

FYA 2021-08-12

Disposable Surgical Gown

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K number K210510

View details →

FYA 2021-07-22

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K number K210143

View details →

FYA 2021-07-21

AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown

Applicant O&M Halyard, Inc.

K number K210688

View details →

FYA 2021-07-07

Surgical Gowns

Applicant Jiangsu Province Jianerkang Medical Dressing Co., Ltd.

K number K210215

View details →

FYA 2021-07-02

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown

Applicant Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

K number K211422

View details →

FYA 2021-04-02

Medline Orbis Surgical Gown

Applicant Medline Industries, Inc.

K number K202447

View details →

FYA 2021-01-06

Medical Surgical Gowns

Applicant Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K number K202844

View details →

FYA 2020-12-31

Surgical Gown (Sterile), Surgical Gown (Non-sterile)

Applicant B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

K number K202706

View details →

FYA 2020-08-05

Modular Toga

Applicant Operating Room Innovations, Inc.

K number K200977

View details →

FYA 2020-07-29

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

Applicant Cardinal Health200, LLC

K number K200824

View details →

FYA 2020-05-22

Surgical Gown

Applicant Shandong Kangli Medical Equipment Technology Co., Ltd.

K number K192560

View details →

FYA 2020-04-30

50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown

Applicant Xuchang Zhengde Environstar Medical Products Co., Ltd.

K number K192290

View details →

FYA 2020-03-20

Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve

Applicant Cardinal Health200, LLC

K number K193327

View details →

FYA 2020-03-16

AERO CHROME* Breathable Performance Surgical Gowns

Applicant O&M Halyard, Inc.

K number K200522

View details →

FYA 2019-12-13

Aero Blue Performance Surgical Gowns

Applicant O&M Halyard, Inc.

K number K192362

View details →

FYA 2019-10-15

TotalShield II Surgical Helmet System

Applicant Zimmer Surgical, Inc.

K number K192194

View details →

FYA 2019-07-04

Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)

Applicant Medline Industries, Inc.

K number K190950

View details →

FYA 2019-04-24

Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)

Applicant Medline Industries, Inc.

K number K182172

View details →

FYA 2019-01-16

Disposable Ultra Reinforced Surgical Gown

Applicant Xiantao Rayxin Medical Products Co., Ltd.

K number K173847

View details →

FYA 2018-07-13

Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)

Applicant Gmax Industries, Inc.

K number K172987

View details →

FYA 2018-06-15

Medline Prevention CoolZone Gown

Applicant Medline Industries, Inc.

K number K172954

View details →

FYA 2017-12-08

RoyalGuard Surgical Gown, i600, Breathable

Applicant Gri Medical & Electrical Technology Co., Ltd.

K number K172445

View details →

FYA 2017-06-09

Cardinal Health Non-Reinforced Surgical Gown

Applicant Cardinal Health200, LLC

K number K170762

View details →

FYA 2017-04-21

Aero Chrome* Select Breathable Performance Surgical Gowns

Applicant Halyard Health, Inc.

K number K162930

View details →

FYA 2017-02-27

ComfortGuard Surgical Gown, i600, Film Reinforced

Applicant Gri Medical & Electrical Technology Co., Ltd.

K number K163191

View details →

FYA 2016-12-12

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

Applicant Gri Medical & Electrical Technology Co., Ltd.

K number K162442

View details →

FYA 2016-04-28

Blockade Surgical Gown

Applicant Medline Industries, Inc.

K number K150598

View details →

FYA 2016-04-13

Aero Chrome* Breathable Performance Surgical Gown

Applicant Halyard Health, Inc.

K number K153255

View details →

FYA 2013-12-23

TOTALSHIELD SURGICAL HELMET SYSTEM

Applicant Zimmer, Inc.

K number K132386

View details →

FYA 2013-09-12

SURGICAL GOWN (EO STERILIZED)

Applicant Cobes Industries Co., Ltd.

K number K112796

View details →

FYA 2012-12-20

HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED

Applicant Changzhou Holymed Products Co., Ltd.

K number K121998

View details →

FYA 2012-12-12

SURGICAL GOWN, SMS

Applicant Jiangsu Guangda Medical Material, Co., Ltd.

K number K121152

View details →

FYA 2012-10-16

DISPOSABLE SURGICAL GOWNS

Applicant Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

K number K120192

View details →

FYA 2012-06-12

EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV

Applicant Exact Medical Manufacturing, Inc.

K number K120045

View details →

FYA 2011-08-26

EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER

Applicant Exact Medical Manufacturing, Inc.

K number K111535

View details →

FYA 2011-08-02

JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE

Applicant Kunshan Jiehong Nonwoven Product Co., Ltd.

K number K111067

View details →

↑