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 |
|---|---|---|---|
| Sep 17, 1996 | K961239 | DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL Depuy, Inc. | FYA |
| Aug 30, 1996 | K955586 | ROBISON & SMITH SURGICAL PACKS Robison & Smith, Inc. | FYA |
| Aug 23, 1996 | K961083 | OREX SURGEON'S VEST Thantex Specialties, Inc. | FYA |
| Jul 12, 1996 | K960073 | EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP Safetec of America, Inc. | FYA |
| Sep 5, 1995 | K953251 | MERTEX-PLUS O.R./SURGEONS GOWN Mercana Industries , Ltd., CA | FYA |
| Aug 28, 1995 | K944393 | STRYKER STERI-SHIELD SURGICAL APPAREL Stryker Corp. | FYA |
| Aug 18, 1995 | K951623 | TLC SURGICAL GOWNS Tlc Tech Lab Clothes, Inc. | FYA |
| Jul 25, 1995 | K951984 | WHITE KNIGHT SURGEON'S VEST White Knight Healthcare | FYA |
| Apr 27, 1995 | K945371 | COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Apr 25, 1995 | K950504 | PERVAL SURGICAL GOWN (MARKETING NAME) Standard Textile Co., Inc. | FYA |
| Mar 22, 1995 | K945658 | INTERWOVEN(TM) REUSABLE SURGICAL GOWN Baxter Healthcare Corp | FYA |
| Feb 28, 1995 | K944827 | OREX SURGEON'S GOWN Thantex Specialties, Inc. | FYA |
| Dec 20, 1994 | K944138 | INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL Baxter Healthcare Corp | FYA |
| Oct 7, 1994 | K931562 | GUARDIAN SURGEON'S GOWNS Atkins Healthcare Services | FYA |
| Jul 26, 1994 | K940931 | ASEP(TM) PLUS SURGICAL GOWN Angelica Uniform Group, Inc. | FYA |
| Jul 8, 1994 | K931456 | SURGICAL DRAPE AND GOWN TRAY Custom Medical Products, Ltd. | FYA |
| Jun 10, 1994 | K931144 | STERILE SURGEON'S GOWN, MODIFICATION Amsco Sterile Recoveries, Inc. | FYA |
| May 24, 1994 | K934664 | HYDRAGOWN Mallinckrodt Group, Inc. | FYA |
| Apr 22, 1994 | K940758 | COMPEL SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Apr 11, 1994 | K934608 | BARRIER FABRIC 450 SURGICAL GOWN Johnson & Johnson Medical, Inc. | FYA |
| Mar 29, 1994 | K932694 | KAPPLER PRO/VENT PROCEDURE GOWN Kappler, Inc. | FYA |
| Mar 18, 1994 | K940069 | DRESSING CHANGE KIT Mason-Keller Corp. | FYA |
| Mar 7, 1994 | K935660 | MEDICOTEX(TRADEMARK APPLICATION PENDING) Itochu International, Inc. | FYA |
| Feb 10, 1994 | K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX 3M Health Care, Ltd. | FYA |
| Aug 27, 1993 | K924055 | N-PAC National Healthcare Linen Service | FYA |
| Aug 12, 1993 | K926519 | SURGICAL GOWN Custom Medical Products, Ltd. | FYA |
| Jul 9, 1993 | K921158 | O.R./SURGEONS GOWN, ITEM NO. 4950 The Sewing Source, Inc. | FYA |
| Jul 9, 1993 | K921157 | O.R./SURGEONS GOWN, ITEM NO. 4942 The Sewing Source, Inc. | FYA |
| Jul 9, 1993 | K921156 | O.R./SURGEONS GOWN, ITEM NO.4941 The Sewing Source, Inc. | FYA |
| Jul 9, 1993 | K921155 | O.R./SURGEONS GOWN, ITEM NO. 4962 The Sewing Source, Inc. | FYA |
| Jul 9, 1993 | K921154 | O.R./SURGEONS GOWN, ITEM NO. 4962 The Sewing Source, Inc. | FYA |
| Jul 9, 1993 | K921153 | O.R./SURGEONS GOWN, ITEM NO. 4960 The Sewing Source, Inc. | FYA |
| Jul 9, 1993 | K921152 | O.R./SURGEONS GOWN, ITEM NO. 4952 The Sewing Source, Inc. | FYA |
| Jul 9, 1993 | K921151 | O.R./SURGEONS GOWN, ITEM NO. 4951 The Sewing Source, Inc. | FYA |
| Jun 11, 1993 | K932003 | N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) National Healthcare Linen Service | FYA |
| May 11, 1993 | K925715 | RS OPTIGUARD GOWN & DRAPE MATERIAL Baxter Healthcare Corp | FYA |
| Mar 31, 1993 | K923815 | TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS Laivan Corp. | FYA |
| Mar 9, 1993 | K922753 | COMPEL XTR Standard Textile Co., Inc. | FYA |
| Feb 18, 1993 | K921889 | COMPEL O AND R Standard Textile Co., Inc. | FYA |
| Feb 16, 1993 | K922949 | SURGICAL GOWN Robert J. Sislian, Inc. | FYA |
| Oct 22, 1992 | K920568 | STERILE DISPOSABLE SURGICAL GOWN W/ TOWEL Border Opportunity Saver Systems, Inc. | FYA |
| Aug 18, 1992 | K920405 | STERILE SURGEON'S GOWN Amsco Sterile Recoveries, Inc. | FYA |
| May 31, 1992 | K920996 | BARRIER SURGICAL GOWN WITH SYMETRY FABRIC Johnson & Johnson Medical, Inc. | FYA |
| May 22, 1992 | K920837 | STERILE CONVERTOR SAFECARE GOWN AND DRAPE Baxter Healthcare Corp | FYA |
| Apr 29, 1992 | K915502 | MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES Medline | FYA |
| Apr 14, 1992 | K914235 | ASEP SURGEONS GOWN Baxter Interwoven Offsite | FYA |
| Apr 2, 1992 | K914839 | COMPEL E Standard Textile Co., Inc. | FYA |
| Jan 10, 1992 | K914563 | STERILE SUGICAL GOWN PACK Assured Surgical Products, Inc. | FYA |
| Jan 10, 1992 | K912803 | MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL Medical Sterilization, Inc. | FYA |
| Jun 17, 1991 | K911508 | MAGNA SURGEONS GOWNS Dms Miami, Inc., GW | FYA |
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