Atlas FDA

FYC

68 FDA 510(k) clearances · Product code

144 daysmedian time to decision
391 days90th percentile
68clearances measured

FDA profile

Official device name
Gown, Isolation, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
1994: 1 · 1995: 2 · 1997: 1 · 2013: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) (K232849)Owens & Minor (O&M) Halyard, Inc.2024-05-16
Copioumed Chemotherapy Isolation Gown (K230135)Copioumed International, Inc.2023-10-04
Disposable Isolation Gown (K223467)Nanning Tecbod Biological Technology Co., Ltd.2023-02-10
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (K223304)Xiamen Probtain Medical Technology Co., Ltd.2023-02-08
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (K223411)Xiamen Probtain Medical Techology Co., Ltd.2023-01-04
Paneffort AAMI Level 3 Isolation Gown (K212717)Paneffort, LLC2022-11-30
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown (K210414)Medtecs (Taiwan) Corp.2022-10-21
AAMI4 Isolation Gown (K214116)Hubei Xinxin Non-Woven Co., Ltd.2022-10-11
Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (K221027)Allmed Medical (Hubei) Protective Products Co., Ltd.2022-08-12
Surgical Isolation Cover Gown (K220528)Wuhan Dymex Healthcare Co., Ltd.2022-06-10
AAMI3 Isolation Gown (K213832)Hubei Xinxin Non-Woven Co., Ltd.2022-05-16
Disposable Surgical Isolation Gown (K212422)Crown Name Disposable Hygiene Products Fty., Ltd.2022-04-29
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) (K210148)Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.2022-04-13
Plus Medical Isolation Gown Level 3 (K212698)Foshan Nanhai Plus Medical Co, Ltd.2022-03-02
Surgical isolation gown (K212357)Wuhan Zonsen Medical Products Co., Ltd.2022-01-20
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue (K212633)String King Lacrosse, LLC2021-11-24
Protect X Level 3 Isolation Gown (K211538)Azac Group2021-11-17
Disposable Surgical Gowns (K210785)Chongqing Litai Fashion Group Limited Company2021-11-13
Isolation Gown AAMI Level 3 (K212504)Kenpax International Limited2021-11-07
ComfortGuard Surgical Isolation Gown (K210131)Gri-Alleset, Inc.2021-08-26
Surgical Isolation Gown (K203415)Yanbian Pacific Textile Co., Ltd.2021-05-20
Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back (K202310)Wildcat Ppe, LLC2021-01-29
AMD Ritmed AssureWear VersaGown (K190306)Amd Medicom, Inc.2020-01-17
SURGICAL ISOLATION GOWN (K171535)Jingzhou Haixin Green Cross Medical Products Co., Ltd.2018-02-15
Medline Non-Surgical Isolation Gown- (K160471)Medline Industries, Inc.2017-01-31
PRIMAGARD Isolation Gown (AAMI PB70 Level 3) (K160361)Primed Medical Products, Inc.2016-11-04
Cardinal Health Isolation Gown (K160339)Cardinal Health200, LLC2016-07-28
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN (K003749)Banta Healthcare2001-02-23
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS (K982369)Allegiance Healthcare Corp.1998-08-24
KENTRON'S ISOLATION GOWN (K971917)Kentron Health Care, Inc.1997-09-19
IMPERVIOUS ISOLATION GOWN (K972410)Kentron Health Care, Inc.1997-09-19
FAR-EAST BARRIER GOWNS (K971702)Far East Science & Technology Development Co., Ltd.1997-07-08
NON-STERILE ISOLATION GOWN (K970814)American Seal Co.1997-05-27
ISOLATION GOWN (K960999)Copioumed Intl., Inc.1996-12-30
SURGICAL APPAREL (K954549)Global Healthcare, Inc.1996-04-18
NIOMED BARRIER GOWNS (K954747)Amerasia Corp.1996-03-06
BARRIER GOWN, KOOL-GARD BACKLESS GOWN (K952115)American Threshold Industries, Inc.1995-09-25
KOOL GARD SINGLES GOWN (K952114)American Threshold Industries, Inc.1995-09-25
COVER GOWN (K952116)American Threshold Industries, Inc.1995-09-05
DI ISOLATION GOWN (K942351)Derekduck Industries Corp.1995-05-17
BUSE STAFF PROTECTION GOWNS AND KITS (K941845)Busse Hospital Disposables, Inc.1995-05-10
OREX ISOLATION GOWN (K945223)Thantex Specialties, Inc.1995-04-25
NON-STERILE ISOLATION GOWN (K931145)Amsco Sterile Recoveries, Inc.1994-06-10
TBC TRAUMA SUIT PROTECTIVE GOWN (K923162)Tbc, Inc.1994-04-04
ISOLATION GOWNS (K922442)Pfb Inter-Apparel Corp.1993-10-12
POLY-MED DISPOSABLE PERSONAL PROTECTION KIT (K930026)Medtek Development Corp.1993-10-04
POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS (K925077)Medtek Development Corp.1993-08-16
DYNASTY IMPERVIOUS ISOLATION J-SUIT (K923188)Dynatech Medical Products1993-01-29
SURGEON'S GOWN (K920404)Amsco Sterile Recoveries, Inc.1992-08-18
DISPOSABLE ISOLATION GOWN (K921058)Nat'L Surtex Corp.1992-08-11
DYNASTY ISOLATION GOWN (K922234)Dynatech Medical Products1992-08-11
SURGICAL GOWNS, EXTRA-LARGE SIZE (K910410)Dawn of Hope Development Center1991-04-25
COATED ISOLATION GOWN (K891677)Durante Intl., Inc.1989-04-20
SURGICAL GARMENTS (K880484)Greene International Corp.1988-06-27
GOWN, ISOLATION, SURGICAL (FYC) (K882281)A Plus International, Inc.1988-06-23
ISOLATION GOWN (K874888)Sage Products, Inc.1987-12-30
INTERPRO INT'L, INC. ISOLATION GOWN (K874766)Interpro Intl., Inc.1987-12-10
MAXIMUM CONTROL GOWN (K874318)Ulti-Med Intl., Inc.1987-12-02
CARETEX ISOLUTION GOWNS (K864479)James River Corp.1986-12-09
DISPOSABLE ISOLATION GOWN (K851823)American Threshold Industries, Inc.1985-05-17
NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR (K844786)Durawear1985-01-18
CONTROL COVER GOWN (K840229)Kimberly-Clark Corp.1984-03-19
BARRIER PLUS SURGEON GOWNS (K801162)American Hospital Supply Corp.1980-05-23
STERILE ISOLATION GOWN (K801069)Medspec Corp.1980-05-20
ISOLATION GOWN (K780605)Abco Dealers, Inc.1978-05-09
ISOLATION GOWN (K770488)General Medical Co.1977-05-23
ISOLATION GOWN PACK (K761080)American Hospital Supply Corp.1977-01-28
CLEANING AND ISOLATION ROOM KIT (K760904)American Hospital Supply Corp.1976-12-30

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Every clearance here is in the API, with alerts when new ones post.