Product code FYC

Product
Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical De
Definition
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Description
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Regulation number
Radiation type
Radiation Emitting Electronic Product Codes // Qui
Applicable standards
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -

Current FDA Classification

Device name
Gown, Isolation, Surgical
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4040
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related Records

Related 510(k) Records

510(k)DeviceApplicantDecision date
K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.2024-05-16
K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.2023-10-04
K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.2023-02-10
K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.2023-02-08
K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.2023-01-04
K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC2022-11-30
K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo GownMedtecs (Taiwan) Corp.2022-10-21
K214116AAMI4 Isolation GownHubei Xinxin Non-Woven Co., Ltd.2022-10-11
K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))Allmed Medical (Hubei) Protective Products Co., Ltd.2022-08-12
K220528Surgical Isolation Cover GownWuhan Dymex Healthcare Co., Ltd.2022-06-10
K213832AAMI3 Isolation GownHubei Xinxin Non-Woven Co., Ltd.2022-05-16
K212422Disposable Surgical Isolation GownCrown Name Disposable Hygiene Products Fty., Ltd.2022-04-29
K210148Flosteril 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)Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.2022-04-13
K212698Plus Medical Isolation Gown Level 3Foshan Nanhai Plus Medical Co, Ltd.2022-03-02
K212357Surgical isolation gownWuhan Zonsen Medical Products Co., Ltd.2022-01-20
K212633Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, BlueString King Lacrosse, LLC2021-11-24
K211538Protect X Level 3 Isolation GownAzac Group2021-11-17
K210785Disposable Surgical GownsChongqing Litai Fashion Group Limited Company2021-11-13
K212504Isolation Gown AAMI Level 3Kenpax International Limited2021-11-07
K210131ComfortGuard Surgical Isolation GownGri-Alleset, Inc.2021-08-26
K203415Surgical Isolation GownYanbian Pacific Textile Co., Ltd.2021-05-20
K202310Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full BackWildcat Ppe, LLC2021-01-29
K190306AMD Ritmed AssureWear VersaGownAmd Medicom, Inc.2020-01-17
K171535SURGICAL ISOLATION GOWNJingzhou Haixin Green Cross Medical Products Co., Ltd.2018-02-15
K160471Medline Non-Surgical Isolation Gown-Medline Industries, Inc.2017-01-31
K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc.2016-11-04
K160339Cardinal Health Isolation GownCardinal Health200, LLC2016-07-28
K003749100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWNBanta Healthcare2001-02-23
K982369CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNSAllegiance Healthcare Corp.1998-08-24
K972410IMPERVIOUS ISOLATION GOWNKentron Health Care, Inc.1997-09-19

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