Gown, Isolation, Surgical

FDA product code FYC · 68 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: 1976-12-30 – 2024-05-16

FYC 2024-05-16

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

Applicant Owens & Minor (O&M) Halyard, Inc.

K number K232849

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FYC 2023-10-04

Copioumed Chemotherapy Isolation Gown

Applicant Copioumed International, Inc.

K number K230135

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FYC 2023-02-10

Disposable Isolation Gown

Applicant Nanning Tecbod Biological Technology Co., Ltd.

K number K223467

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FYC 2023-02-08

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

Applicant Xiamen Probtain Medical Technology Co., Ltd.

K number K223304

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FYC 2023-01-04

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

Applicant Xiamen Probtain Medical Techology Co., Ltd.

K number K223411

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FYC 2022-11-30

Paneffort AAMI Level 3 Isolation Gown

Applicant Paneffort, LLC

K number K212717

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FYC 2022-10-21

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown

Applicant Medtecs (Taiwan) Corp.

K number K210414

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FYC 2022-10-11

AAMI4 Isolation Gown

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K number K214116

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FYC 2022-08-12

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

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

K number K221027

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FYC 2022-06-10

Surgical Isolation Cover Gown

Applicant Wuhan Dymex Healthcare Co., Ltd.

K number K220528

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FYC 2022-05-16

AAMI3 Isolation Gown

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K number K213832

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FYC 2022-04-29

Disposable Surgical Isolation Gown

Applicant Crown Name Disposable Hygiene Products Fty., Ltd.

K number K212422

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FYC 2022-04-13

Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)

Applicant Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.

K number K210148

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FYC 2022-03-02

Plus Medical Isolation Gown Level 3

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K number K212698

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FYC 2022-01-20

Surgical isolation gown

Applicant Wuhan Zonsen Medical Products Co., Ltd.

K number K212357

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FYC 2021-11-24

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue

Applicant String King Lacrosse, LLC

K number K212633

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FYC 2021-11-17

Protect X Level 3 Isolation Gown

Applicant Azac Group

K number K211538

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FYC 2021-11-13

Disposable Surgical Gowns

Applicant Chongqing Litai Fashion Group Limited Company

K number K210785

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FYC 2021-11-07

Isolation Gown AAMI Level 3

Applicant Kenpax International Limited

K number K212504

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FYC 2021-08-26

ComfortGuard Surgical Isolation Gown

Applicant Gri-Alleset, Inc.

K number K210131

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FYC 2021-05-20

Surgical Isolation Gown

Applicant Yanbian Pacific Textile Co., Ltd.

K number K203415

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FYC 2021-01-29

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back

Applicant Wildcat Ppe, LLC

K number K202310

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FYC 2020-01-17

AMD Ritmed AssureWear VersaGown

Applicant Amd Medicom, Inc.

K number K190306

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FYC 2018-02-15

SURGICAL ISOLATION GOWN

Applicant Jingzhou Haixin Green Cross Medical Products Co., Ltd.

K number K171535

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FYC 2017-01-31

Medline Non-Surgical Isolation Gown-

Applicant Medline Industries, Inc.

K number K160471

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FYC 2016-11-04

PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

Applicant Primed Medical Products, Inc.

K number K160361

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FYC 2016-07-28

Cardinal Health Isolation Gown

Applicant Cardinal Health200, LLC

K number K160339

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FYC 2001-02-23

100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN

Applicant Banta Healthcare

K number K003749

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FYC 1998-08-24

CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS

Applicant Allegiance Healthcare Corp.

K number K982369

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FYC 1997-09-19

IMPERVIOUS ISOLATION GOWN

Applicant Kentron Health Care, Inc.

K number K972410

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FYC 1997-09-19

KENTRON'S ISOLATION GOWN

Applicant Kentron Health Care, Inc.

K number K971917

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FYC 1997-07-08

FAR-EAST BARRIER GOWNS

Applicant Far East Science & Technology Development Co., Ltd.

K number K971702

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FYC 1997-05-27

NON-STERILE ISOLATION GOWN

Applicant American Seal Co.

K number K970814

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FYC 1996-12-30

ISOLATION GOWN

Applicant Copioumed Intl., Inc.

K number K960999

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FYC 1996-04-18

SURGICAL APPAREL

Applicant Global Healthcare, Inc.

K number K954549

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FYC 1996-03-06

NIOMED BARRIER GOWNS

Applicant Amerasia Corp.

K number K954747

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FYC 1995-09-25

BARRIER GOWN, KOOL-GARD BACKLESS GOWN

Applicant American Threshold Industries, Inc.

K number K952115

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FYC 1995-09-25

KOOL GARD SINGLES GOWN

Applicant American Threshold Industries, Inc.

K number K952114

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FYC 1995-09-05

COVER GOWN

Applicant American Threshold Industries, Inc.

K number K952116

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FYC 1995-05-17

DI ISOLATION GOWN

Applicant Derekduck Industries Corp.

K number K942351

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FYC 1995-05-10

BUSE STAFF PROTECTION GOWNS AND KITS

Applicant Busse Hospital Disposables, Inc.

K number K941845

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FYC 1995-04-25

OREX ISOLATION GOWN

Applicant Thantex Specialties, Inc.

K number K945223

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FYC 1994-06-10

NON-STERILE ISOLATION GOWN

Applicant Amsco Sterile Recoveries, Inc.

K number K931145

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FYC 1994-04-04

TBC TRAUMA SUIT PROTECTIVE GOWN

Applicant Tbc, Inc.

K number K923162

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FYC 1993-10-12

ISOLATION GOWNS

Applicant Pfb Inter-Apparel Corp.

K number K922442

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FYC 1993-10-04

POLY-MED DISPOSABLE PERSONAL PROTECTION KIT

Applicant Medtek Development Corp.

K number K930026

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FYC 1993-08-16

POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS

Applicant Medtek Development Corp.

K number K925077

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FYC 1993-01-29

DYNASTY IMPERVIOUS ISOLATION J-SUIT

Applicant Dynatech Medical Products

K number K923188

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FYC 1992-08-18

SURGEON'S GOWN

Applicant Amsco Sterile Recoveries, Inc.

K number K920404

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FYC 1992-08-11

DYNASTY ISOLATION GOWN

Applicant Dynatech Medical Products

K number K922234

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FYC 1992-08-11

DISPOSABLE ISOLATION GOWN

Applicant Nat'L Surtex Corp.

K number K921058

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FYC 1991-04-25

SURGICAL GOWNS, EXTRA-LARGE SIZE

Applicant Dawn of Hope Development Center

K number K910410

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FYC 1989-04-20

COATED ISOLATION GOWN

Applicant Durante Intl., Inc.

K number K891677

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FYC 1988-06-27

SURGICAL GARMENTS

Applicant Greene International Corp.

K number K880484

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FYC 1988-06-23