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FYA

297 FDA 510(k) clearances · Product code

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RecordFirmDate
ROBISON & SMITH SURGICAL PACKS (K955586)Robison & Smith, Inc.1996-08-30
OREX SURGEON'S VEST (K961083)Thantex Specialties, Inc.1996-08-23
EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP (K960073)Safetec of America, Inc.1996-07-12
MERTEX-PLUS O.R./SURGEONS GOWN (K953251)Mercana Industries , Ltd.1995-09-05
STRYKER STERI-SHIELD SURGICAL APPAREL (K944393)Stryker Corp.1995-08-28
TLC SURGICAL GOWNS (K951623)Tlc Tech Lab Clothes, Inc.1995-08-18
WHITE KNIGHT SURGEON'S VEST (K951984)White Knight Healthcare1995-07-25
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS (K945371)Standard Textile Co., Inc.1995-04-27
PERVAL SURGICAL GOWN (MARKETING NAME) (K950504)Standard Textile Co., Inc.1995-04-25
INTERWOVEN(TM) REUSABLE SURGICAL GOWN (K945658)Baxter Healthcare Corp1995-03-22
OREX SURGEON'S GOWN (K944827)Thantex Specialties, Inc.1995-02-28
INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL (K944138)Baxter Healthcare Corp1994-12-20
GUARDIAN SURGEON'S GOWNS (K931562)Atkins Healthcare Services1994-10-07
ASEP(TM) PLUS SURGICAL GOWN (K940931)Angelica Uniform Group, Inc.1994-07-26
SURGICAL DRAPE AND GOWN TRAY (K931456)Custom Medical Products, Ltd.1994-07-08
STERILE SURGEON'S GOWN, MODIFICATION (K931144)Amsco Sterile Recoveries, Inc.1994-06-10
HYDRAGOWN (K934664)Mallinckrodt Group, Inc.1994-05-24
COMPEL SURGICAL GOWNS (K940758)Standard Textile Co., Inc.1994-04-22
BARRIER FABRIC 450 SURGICAL GOWN (K934608)Johnson & Johnson Medical, Inc.1994-04-11
KAPPLER PRO/VENT PROCEDURE GOWN (K932694)Kappler, Inc.1994-03-29
DRESSING CHANGE KIT (K940069)Mason-Keller Corp.1994-03-18
MEDICOTEX(TRADEMARK APPLICATION PENDING) (K935660)Itochu International, Inc.1994-03-07
3M PREVENTION FABRIC SURGICAL GOWN #78XX (K930681)3M Health Care, Ltd.1994-02-10
N-PAC (K924055)National Healthcare Linen Service1993-08-27
SURGICAL GOWN (K926519)Custom Medical Products, Ltd.1993-08-12
O.R./SURGEONS GOWN, ITEM NO. 4951 (K921151)The Sewing Source, Inc.1993-07-09
O.R./SURGEONS GOWN, ITEM NO. 4960 (K921153)The Sewing Source, Inc.1993-07-09
O.R./SURGEONS GOWN, ITEM NO.4941 (K921156)The Sewing Source, Inc.1993-07-09
O.R./SURGEONS GOWN, ITEM NO. 4962 (K921154)The Sewing Source, Inc.1993-07-09
O.R./SURGEONS GOWN, ITEM NO. 4950 (K921158)The Sewing Source, Inc.1993-07-09
O.R./SURGEONS GOWN, ITEM NO. 4942 (K921157)The Sewing Source, Inc.1993-07-09
O.R./SURGEONS GOWN, ITEM NO. 4962 (K921155)The Sewing Source, Inc.1993-07-09
O.R./SURGEONS GOWN, ITEM NO. 4952 (K921152)The Sewing Source, Inc.1993-07-09
N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) (K932003)National Healthcare Linen Service1993-06-11
RS OPTIGUARD GOWN & DRAPE MATERIAL (K925715)Baxter Healthcare Corp1993-05-11
TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS (K923815)Laivan Corp.1993-03-31
COMPEL XTR (K922753)Standard Textile Co., Inc.1993-03-09
COMPEL O AND R (K921889)Standard Textile Co., Inc.1993-02-18
SURGICAL GOWN (K922949)Robert J. Sislian, Inc.1993-02-16
STERILE DISPOSABLE SURGICAL GOWN W/ TOWEL (K920568)Border Opportunity Saver Systems, Inc.1992-10-22
STERILE SURGEON'S GOWN (K920405)Amsco Sterile Recoveries, Inc.1992-08-18
BARRIER SURGICAL GOWN WITH SYMETRY FABRIC (K920996)Johnson & Johnson Medical, Inc.1992-05-31
STERILE CONVERTOR SAFECARE GOWN AND DRAPE (K920837)Baxter Healthcare Corp1992-05-22
MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES (K915502)Medline1992-04-29
ASEP SURGEONS GOWN (K914235)Baxter Interwoven Offsite1992-04-14
COMPEL E (K914839)Standard Textile Co., Inc.1992-04-02
MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL (K912803)Medical Sterilization, Inc.1992-01-10
STERILE SUGICAL GOWN PACK (K914563)Assured Surgical Products, Inc.1992-01-10
MAGNA SURGEONS GOWNS (K911508)Dms Miami, Inc.1991-06-17
FREEDOM MARK III SURGICAL HELMET SYSTEM (K910515)Stackhouse Assoc.1991-05-06
GOWN, OPERATING SURGICAL (K911568)Huntsville Rehabilitation Foundation1991-04-22
STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV (K901536)Depuy, Inc.1990-11-29
SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM* (K902348)Futuristic Medical Concepts, Inc.1990-09-06
CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE (K896935)Baxter Healthcare Corp1990-02-16
SHIRT, OPERATING, SURGICAL (K894599)Miroz Industries Co.1989-08-11
GOWN, OPERATING, SURGICAL (K894284)Miroz Industries Co.1989-07-14
NON-STERILE MASKS AND CAPS (K892118)Paramount Products, Inc.1989-04-20
SURGICAL GOWN #2001 (K891211)Pro-Safe Professional Linens, Inc.1989-04-14
DENTAL GOWN (K891058)Dispomed, Inc.1989-04-12
SURGICAL GOWNS (K890474)Victoria Slipper Retail & Mfg., Co.1989-02-23
SURGICAL SHIRT (K883464)Arkansas Lighthouse For the Blind1988-08-26
STERILE DISPOSABLE SURGICAL GOWNS (K882470)Bolden Products, Div. of the Transport Group1988-08-03
KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN (K880382)Kimberly-Clark Corp.1988-06-23
KIMBERLY-CLARK PROTECTIVE SLEEVE (K880386)Kimberly-Clark Corp.1988-06-23
KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON (K880383)Kimberly-Clark Corp.1988-06-23
THEATRE GOWNS (K872758)Smith & Nephew, Inc.1987-07-31
UNIMED SURGEON'S GOWNS (K871906)Unimed Hospital Supply Corp.1987-06-09
STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) (K864311)Clinitech, Inc.1986-11-26
SPUNGUARD PLUS SURGICAL GOWN (K861600)Kimberly-Clark Corp.1986-05-12
BARRIER SURGICAL GOWN (K852870)Surgikos, Inc.1985-07-23
OMNIMED SURGICAL GOWN (K851938)Omni Intl., Inc.1985-06-28
TURQUOISE (K851559)Roseburg SA1985-04-30
MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN) (K850177)Matrix Medica, Inc.1985-02-21
GOWNS, SURGICAL (K844703)Medicon, Inc.1985-01-10
BOUNDARY SINGLE-USE OR GOWN (K842958)Procter & Gamble Mfg. Co.1984-08-17
BOUNDARY SINGLE-USE GOWNS (K834332)Procter & Gamble Mfg. Co.1984-05-01
BOUNDARY SINGLE-USE GOWNS (K822925)The Buckeye Cellulose Corp.1983-01-12
BOUNDARY PROCESS CHANGE (K821564)The Buckeye Cellulose Corp.1982-07-02
DISPOSABLE SURGICAL GARMENTS (K820363)Alphamedix, Inc.1982-03-08
BOUNDARY (K820116)The Buckeye Cellulose Corp.1982-02-23
BONDARY SINGLE-USE OR GOWN (K813390)The Buckeye Cellulose Corp.1982-01-05
BOUNDARY REINFORCED OR GOWN (K811958)The Buckeye Cellulose Corp.1981-07-27
IRRADIATED BOUNDARY DEVICES (K803158)The Buckeye Cellulose Corp.1981-01-15
L.A.F. ISOLATION PACK (K802885)Action Medical Systems, Inc.1981-01-15
ODOR MASKING AGENT FOR CONTENTS OF ALL (K801025)The Buckeye Cellulose Corp.1980-05-30
WHITE KNIGHT DISP. STERILE BACK GOWN (K800927)G.D. Searle and Co.1980-05-20
WHITE KNIGHT SURGICAL PACK (K800929)G.D. Searle and Co.1980-05-20
ULTRASOFT GOWN (K800124)Mars Mfg Co.1980-02-05
STERILIZATION PROCESS /USE GOWNS (K792622)Procter & Gamble Mfg. Co.1980-01-11
BOUNDARY SPECIALTY GOWN (K791062)Procter & Gamble Mfg. Co.1979-06-20
SURGICAL GOWNS & DRAPES (K781682)Kimberly-Clark Corp.1978-12-20
SURGICAL GOWNS AND DRAPES (K781099)Convertors1978-08-14
SURGICAL GOWN, REINFORCED (K772182)Surgikos, Inc.1977-12-08
APPAREL, BARRIER SCRUB (K760554)Surgikos, Inc.1976-11-12
BARRIER FABRIC 450 SURGICAL GOWNS (K760903)Surgikos, Inc.1976-11-11
BARRIER FABRIC 450 SPECIALTY GOWN (K760864)Surgikos, Inc.1976-11-03
GOWN, BOUNDARY SINGLE USE REINFORCED (K760237)Procter & Gamble Mfg. Co.1976-08-11
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