Product Code: FYC FDA class 2 21 CFR 878.4040

Gown, Isolation, Surgical

General, Plastic Surgery

An isolation surgical gown is a specialized garment providing a fluid-resistant barrier worn by surgical personnel in cases requiring enhanced isolation precautions, protecting both patient and clinical staff from cross-contamination. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FYC, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: FYC
Device Class: FDA class 2
Regulation Number: 878.4040
Medical Specialty: General, Plastic Surgery
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 68 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K232849	Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)	May 16, 2024	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.
K230135	Copioumed Chemotherapy Isolation Gown	Oct 04, 2023	Substantially Equivalent	Copioumed International, Inc.
K223467	Disposable Isolation Gown	Feb 10, 2023	Substantially Equivalent	Nanning Tecbod Biological Technology Co., Ltd.
K223304	Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)	Feb 08, 2023	Substantially Equivalent	Xiamen Probtain Medical Technology Co., Ltd.
K223411	Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)	Jan 04, 2023	Substantially Equivalent	Xiamen Probtain Medical Techology Co., Ltd.
K212717	Paneffort AAMI Level 3 Isolation Gown	Nov 30, 2022	Substantially Equivalent	Paneffort, LLC
K210414	CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown	Oct 21, 2022	Substantially Equivalent	Medtecs (Taiwan) Corp.
K214116	AAMI4 Isolation Gown	Oct 11, 2022	Substantially Equivalent	Hubei Xinxin Non-Woven Co., Ltd.
K221027	Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))	Aug 12, 2022	Substantially Equivalent	Allmed Medical (Hubei) Protective Products Co., Ltd.
K220528	Surgical Isolation Cover Gown	Jun 10, 2022	Substantially Equivalent	Wuhan Dymex Healthcare Co., Ltd.
K213832	AAMI3 Isolation Gown	May 16, 2022	Substantially Equivalent	Hubei Xinxin Non-Woven Co., Ltd.
K212422	Disposable Surgical Isolation Gown	Apr 29, 2022	Substantially Equivalent	Crown Name Disposable Hygiene Products Fty., Ltd.
K210148	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)	Apr 13, 2022	Substantially Equivalent	Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
K212698	Plus Medical Isolation Gown Level 3	Mar 02, 2022	Substantially Equivalent	Foshan Nanhai Plus Medical Co, Ltd.
K212357	Surgical isolation gown	Jan 20, 2022	Substantially Equivalent	Wuhan Zonsen Medical Products Co., Ltd.
K212633	Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue	Nov 24, 2021	Substantially Equivalent	String King Lacrosse, LLC
K211538	Protect X Level 3 Isolation Gown	Nov 17, 2021	Substantially Equivalent	Azac Group
K210785	Disposable Surgical Gowns	Nov 13, 2021	Substantially Equivalent	Chongqing Litai Fashion Group Limited Company
K212504	Isolation Gown AAMI Level 3	Nov 07, 2021	Substantially Equivalent	Kenpax International Limited
K210131	ComfortGuard Surgical Isolation Gown	Aug 26, 2021	Substantially Equivalent	Gri-Alleset, Inc.
K203415	Surgical Isolation Gown	May 20, 2021	Substantially Equivalent	Yanbian Pacific Textile Co., Ltd.
K202310	Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back	Jan 29, 2021	Substantially Equivalent	Wildcat Ppe, LLC
K190306	AMD Ritmed AssureWear VersaGown	Jan 17, 2020	Substantially Equivalent	Amd Medicom, Inc.
K171535	SURGICAL ISOLATION GOWN	Feb 15, 2018	Substantially Equivalent	Jingzhou Haixin Green Cross Medical Products Co., Ltd.
K160471	Medline Non-Surgical Isolation Gown-	Jan 31, 2017	Substantially Equivalent	Medline Industries, Inc.
K160361	PRIMAGARD Isolation Gown (AAMI PB70 Level 3)	Nov 04, 2016	Substantially Equivalent	Primed Medical Products, Inc.
K160339	Cardinal Health Isolation Gown	Jul 28, 2016	Substantially Equivalent	Cardinal Health200, LLC
K003749	100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN	Feb 23, 2001	Substantially Equivalent	Banta Healthcare
K982369	CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS	Aug 24, 1998	Substantially Equivalent	Allegiance Healthcare Corp.
K972410	IMPERVIOUS ISOLATION GOWN	Sep 19, 1997	Substantially Equivalent	Kentron Health Care, Inc.
K971917	KENTRON'S ISOLATION GOWN	Sep 19, 1997	Substantially Equivalent	Kentron Health Care, Inc.
K971702	FAR-EAST BARRIER GOWNS	Jul 08, 1997	Substantially Equivalent	Far East Science & Technology Development Co., Ltd.
K970814	NON-STERILE ISOLATION GOWN	May 27, 1997	Substantially Equivalent	American Seal Co.
K960999	ISOLATION GOWN	Dec 30, 1996	Substantially Equivalent	Copioumed Intl., Inc.
K954549	SURGICAL APPAREL	Apr 18, 1996	Substantially Equivalent	Global Healthcare, Inc.
K954747	NIOMED BARRIER GOWNS	Mar 06, 1996	Substantially Equivalent	Amerasia Corp.
K952115	BARRIER GOWN, KOOL-GARD BACKLESS GOWN	Sep 25, 1995	Substantially Equivalent	American Threshold Industries, Inc.
K952114	KOOL GARD SINGLES GOWN	Sep 25, 1995	Substantially Equivalent	American Threshold Industries, Inc.
K952116	COVER GOWN	Sep 05, 1995	Substantially Equivalent	American Threshold Industries, Inc.
K942351	DI ISOLATION GOWN	May 17, 1995	Substantially Equivalent	Derekduck Industries Corp.
K941845	BUSE STAFF PROTECTION GOWNS AND KITS	May 10, 1995	Substantially Equivalent	Busse Hospital Disposables, Inc.
K945223	OREX ISOLATION GOWN	Apr 25, 1995	Substantially Equivalent	Thantex Specialties, Inc.
K931145	NON-STERILE ISOLATION GOWN	Jun 10, 1994	Substantially Equivalent	Amsco Sterile Recoveries, Inc.
K923162	TBC TRAUMA SUIT PROTECTIVE GOWN	Apr 04, 1994	Substantially Equivalent	Tbc, Inc.
K922442	ISOLATION GOWNS	Oct 12, 1993	Substantially Equivalent	Pfb Inter-Apparel Corp.
K930026	POLY-MED DISPOSABLE PERSONAL PROTECTION KIT	Oct 04, 1993	Substantially Equivalent	Medtek Development Corp.
K925077	POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS	Aug 16, 1993	Substantially Equivalent	Medtek Development Corp.
K923188	DYNASTY IMPERVIOUS ISOLATION J-SUIT	Jan 29, 1993	Substantially Equivalent	Dynatech Medical Products
K920404	SURGEON'S GOWN	Aug 18, 1992	Substantially Equivalent	Amsco Sterile Recoveries, Inc.
K922234	DYNASTY ISOLATION GOWN	Aug 11, 1992	Substantially Equivalent	Dynatech Medical Products
K921058	DISPOSABLE ISOLATION GOWN	Aug 11, 1992	Substantially Equivalent	Nat'L Surtex Corp.
K910410	SURGICAL GOWNS, EXTRA-LARGE SIZE	Apr 25, 1991	Substantially Equivalent	Dawn of Hope Development Center
K891677	COATED ISOLATION GOWN	Apr 20, 1989	Substantially Equivalent	Durante Intl., Inc.
K880484	SURGICAL GARMENTS	Jun 27, 1988	Substantially Equivalent	Greene International Corp.
K882281	GOWN, ISOLATION, SURGICAL (FYC)	Jun 23, 1988	Substantially Equivalent	A Plus International, Inc.
K874888	ISOLATION GOWN	Dec 30, 1987	Substantially Equivalent	Sage Products, Inc.
K874766	INTERPRO INT'L, INC. ISOLATION GOWN	Dec 10, 1987	Substantially Equivalent	Interpro Intl., Inc.
K874318	MAXIMUM CONTROL GOWN	Dec 02, 1987	Substantially Equivalent	Ulti-Med Intl., Inc.
K864479	CARETEX ISOLUTION GOWNS	Dec 09, 1986	Substantially Equivalent	James River Corp.
K851823	DISPOSABLE ISOLATION GOWN	May 17, 1985	Substantially Equivalent	American Threshold Industries, Inc.
K844786	NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR	Jan 18, 1985	Substantially Equivalent	Durawear
K840229	CONTROL COVER GOWN	Mar 19, 1984	Substantially Equivalent	Kimberly-Clark Corp.
K801162	BARRIER PLUS SURGEON GOWNS	May 23, 1980	Substantially Equivalent	American Hospital Supply Corp.
K801069	STERILE ISOLATION GOWN	May 20, 1980	Substantially Equivalent	Medspec Corp.
K780605	ISOLATION GOWN	May 09, 1978	Substantially Equivalent	Abco Dealers, Inc.
K770488	ISOLATION GOWN	May 23, 1977	Substantially Equivalent	General Medical Co.
K761080	ISOLATION GOWN PACK	Jan 28, 1977	Substantially Equivalent	American Hospital Supply Corp.
K760904	CLEANING AND ISOLATION ROOM KIT	Dec 30, 1976	Substantially Equivalent	American Hospital Supply Corp.