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) | Device | Applicant | Decision date |
|---|---|---|---|
| K232849 | Halyard 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 |
| K230135 | Copioumed Chemotherapy Isolation Gown | Copioumed International, Inc. | 2023-10-04 |
| K223467 | Disposable Isolation Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2023-02-10 |
| K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Technology Co., Ltd. | 2023-02-08 |
| K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-01-04 |
| K212717 | Paneffort AAMI Level 3 Isolation Gown | Paneffort, LLC | 2022-11-30 |
| K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown | Medtecs (Taiwan) Corp. | 2022-10-21 |
| K214116 | AAMI4 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-10-11 |
| K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-08-12 |
| K220528 | Surgical Isolation Cover Gown | Wuhan Dymex Healthcare Co., Ltd. | 2022-06-10 |
| K213832 | AAMI3 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-05-16 |
| K212422 | Disposable Surgical Isolation Gown | Crown Name Disposable Hygiene Products Fty., Ltd. | 2022-04-29 |
| 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) | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. | 2022-04-13 |
| K212698 | Plus Medical Isolation Gown Level 3 | Foshan Nanhai Plus Medical Co, Ltd. | 2022-03-02 |
| K212357 | Surgical isolation gown | Wuhan Zonsen Medical Products Co., Ltd. | 2022-01-20 |
| K212633 | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue | String King Lacrosse, LLC | 2021-11-24 |
| K211538 | Protect X Level 3 Isolation Gown | Azac Group | 2021-11-17 |
| K210785 | Disposable Surgical Gowns | Chongqing Litai Fashion Group Limited Company | 2021-11-13 |
| K212504 | Isolation Gown AAMI Level 3 | Kenpax International Limited | 2021-11-07 |
| K210131 | ComfortGuard Surgical Isolation Gown | Gri-Alleset, Inc. | 2021-08-26 |
| K203415 | Surgical Isolation Gown | Yanbian Pacific Textile Co., Ltd. | 2021-05-20 |
| K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back | Wildcat Ppe, LLC | 2021-01-29 |
| K190306 | AMD Ritmed AssureWear VersaGown | Amd Medicom, Inc. | 2020-01-17 |
| K171535 | SURGICAL ISOLATION GOWN | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | 2018-02-15 |
| K160471 | Medline Non-Surgical Isolation Gown- | Medline Industries, Inc. | 2017-01-31 |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | Primed Medical Products, Inc. | 2016-11-04 |
| K160339 | Cardinal Health Isolation Gown | Cardinal Health200, LLC | 2016-07-28 |
| K003749 | 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN | Banta Healthcare | 2001-02-23 |
| K982369 | CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS | Allegiance Healthcare Corp. | 1998-08-24 |
| K972410 | IMPERVIOUS ISOLATION GOWN | Kentron Health Care, Inc. | 1997-09-19 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10813360021472 | Protexer | ICP MEDICAL, LLC | 2025-08-15 |
| 00688162000030 | Protexer | ICP MEDICAL, LLC | 2025-08-08 |
| 00688162290004 | Protexer | ICP MEDICAL, LLC | 2025-08-08 |
| 00688162390506 | Protexer | ICP MEDICAL, LLC | 2025-08-08 |
| 10813360021465 | Protexer | ICP MEDICAL, LLC | 2025-08-08 |
| 00813360021772 | Protexer | ICP MEDICAL, LLC | 2025-08-08 |
| 10842942015172 | PRIMED | priMED Medical Products Inc | 2025-07-21 |
| 10842942015301 | PRIMED | priMED Medical Products Inc | 2025-07-21 |
| 14719882251617 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251778 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251754 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251730 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251716 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251594 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251570 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251556 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251457 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251433 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251419 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 14719882251396 | Copioumed | COPIOUMED INTERNATIONAL INC. | 2025-07-16 |
| 10842942008297 | PRIMED | priMED Medical Products Inc | 2025-07-15 |
| 10842942008303 | PRIMED | priMED Medical Products Inc | 2025-07-15 |
| 10842942008457 | PRIMED | priMED Medical Products Inc | 2025-07-15 |
| 10842942008464 | PRIMED | priMED Medical Products Inc | 2025-07-15 |
| 10842942011044 | PRIMED | priMED Medical Products Inc | 2025-07-15 |
| 10842942011785 | PRIMED | priMED Medical Products Inc | 2025-07-15 |
| 00850061262196 | Resilient Medical Solutions | Resilient Medical Solutions, LLC | 2025-03-17 |
| 00850061262257 | Resilient Medical Solutions | Resilient Medical Solutions, LLC | 2025-03-17 |
| 00810101310102 | Paneffort | Paneffort, LLC | 2024-12-18 |
| 00810101310331 | Paneffort | Paneffort, LLC | 2024-12-18 |