Panels › General, Plastic Surgery › Product code FYA · Class 2
Gown, Surgical
Regulation 878.4040
10510(k)s in 12 months (298 all time)
5recalls in 12 months (129 all time)
106recalls that name a 510(k)
Top companies in FYA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2013 | K132386 | TOTALSHIELD SURGICAL HELMET SYSTEM Zimmer, Inc. | FYA |
| Sep 12, 2013 | K112796 | SURGICAL GOWN (EO STERILIZED) Cobes Industries Co., Ltd. | FYA |
| Dec 20, 2012 | K121998 | HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED Changzhou Holymed Products Co., Ltd., CN | FYA |
| Dec 12, 2012 | K121152 | SURGICAL GOWN, SMS Jiangsu Guangda Medical Material, Co., Ltd. | FYA |
| Oct 16, 2012 | K120192 | DISPOSABLE SURGICAL GOWNS Weihai Hongyu Nonwoven Fabric Products Co., Ltd., KM | FYA |
| Jun 12, 2012 | K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV Exact Medical Manufacturing, Inc. | FYA |
| Aug 26, 2011 | K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER Exact Medical Manufacturing, Inc. | FYA |
| Aug 2, 2011 | K111067 | JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE Kunshan Jiehong Nonwoven Product Co., Ltd. | FYA |
| Jun 23, 2011 | K110724 | SURGICAL PROCEDURE PACKS Omnia Spa | FYA |
| Apr 14, 2011 | K101468 | 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE 3M Company Corp | FYA |
| Mar 11, 2011 | K102692 | SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO Hangzhou Jincheng Medical Supplier Manufacture Co. | FYA |
| Feb 23, 2011 | K102971 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK Microtek Medical, Inc. | FYA |
| Feb 4, 2011 | K093835 | BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN Bam Corp., Ltd., HK | FYA |
| Feb 3, 2011 | K102652 | NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS Gri Medical & Electronic Technology Co., Ltd. | FYA |
| Dec 23, 2010 | K103406 | MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS Kimberly-Clark Corp. | FYA |
| Sep 27, 2010 | K100971 | ATEK SURGICAL GOWNS Hangzhou Atek Medical & Textile Co., Ltd. | FYA |
| Sep 3, 2010 | K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL Exact Medical Manufacturing, Inc. | FYA |
| Mar 19, 2010 | K093115 | KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 Kimberly-Clark Corp. | FYA |
| Dec 17, 2009 | K092344 | LAC-MAC INNERBLOC LR SURGICAL GOWNS Lac Mac, Ltd. | FYA |
| Nov 12, 2009 | K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) A Plus International, Inc. | FYA |
| Aug 10, 2009 | K091357 | MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 Kimberly-Clark Corp. | FYA |
| May 29, 2009 | K090383 | SRI LEVEL II SURGICAL GOWN Sri Surgical | FYA |
| May 27, 2009 | K091097 | PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 Promedical Products Co., Ltd. | FYA |
| Apr 24, 2009 | K082479 | SKLAR SURGICAL GOWN Sklar Corp. | FYA |
| Nov 13, 2008 | K080723 | SRI LP GOWN Sri/Surgical Express, Inc. | FYA |
| Nov 13, 2008 | K080707 | SRI PLR GOWN Sri/Surgical Express | FYA |
| Sep 3, 2008 | K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN Kimberly-Clark Corp. | FYA |
| Apr 24, 2008 | K080627 | PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A Promedical Products Co., Ltd., CN | FYA |
| Nov 30, 2007 | K073017 | STRYKER STRI-SHIELD FLYTE TOGAS Stryker Instruments, Instruments Div. | FYA |
| May 24, 2007 | K070431 | WELMED, INC. SURGICAL GOWNS Welmed, Inc. | FYA |
| Mar 23, 2007 | K063005 | STRYKER T6 HOODS AND TOGAS Stryker Instruments | FYA |
| Mar 14, 2007 | K062479 | JOYKEY SURGICAL GOWNS (STERILE) Joykey Industryial , Ltd. | FYA |
| Feb 2, 2007 | K070078 | STRYKER T4 HYTREL TOGA Stryker Instruments, Instruments Div. | FYA |
| Jan 25, 2007 | K062899 | MICROTEK MEDICAL SURGICAL GOWN/TOGA Microtek Medical, Inc. | FYA |
| Dec 14, 2006 | K062969 | MEDLINE STERILE DISPOSABLE SURGICAL GOWNS Medline Industries, Inc. | FYA |
| Aug 9, 2006 | K061491 | LAC-MAC INNERBLOC O.R. GOWN Lac Mac, Ltd. | FYA |
| Jun 5, 2006 | K061308 | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N Cardinal Health 200, Inc. | FYA |
| May 2, 2006 | K052824 | KIMBERLY-CLARK PROCEDURE GOWN Kimberly-Clark Corp. | FYA |
| Mar 7, 2006 | K060181 | COMPE1 1 -PLY SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Nov 17, 2005 | K052550 | IMC SURGICAL GOWNS Intl. Medsurg Connection, Inc. | FYA |
| Aug 2, 2005 | K051426 | CARLO SURGICAL GOWN Sofilm Technology Co., Ltd., TW | FYA |
| Jul 1, 2005 | K041653 | COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS Standard Textile Co., Inc. | FYA |
| May 9, 2005 | K050786 | BARRIER SURGICAL GOWNS Molnlycke Health Care | FYA |
| May 5, 2005 | K041540 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Apr 28, 2005 | K041539 | COMPEL SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Mar 16, 2005 | K043004 | STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 Viasys Medsystems | FYA |
| Mar 16, 2005 | K041541 | COMPEL MLR SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Mar 8, 2005 | K043585 | MEDLINE SURGICAL GOWNS Medline Industries, Inc. | FYA |
| Mar 8, 2005 | K043017 | PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS Medline Industries, Inc. | FYA |
| Dec 10, 2004 | K042111 | PROMEDICAL SURGICAL GOWNS Promedical Products Co., Ltd. | FYA |
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