Product code FYA— General, Plastic Surgery

Surgical Gown

Classification name: Gown, Surgical
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Total cleared: 298
First cleared: 1976-08-11
Most recent: 2026-08-26

Clearances under product code FYA — page 3

201–298 of 298

K961239 — DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTRELDepuy, Inc.·1996-09-17
K955586 — ROBISON & SMITH SURGICAL PACKSRobison & Smith, Inc.·1996-08-30
K961083 — OREX SURGEON'S VESTThantex Specialties, Inc.·1996-08-23
K960073 — EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UPSafetec of America, Inc.·1996-07-12
K953251 — MERTEX-PLUS O.R./SURGEONS GOWNMercana Industries , Ltd.·1995-09-05
K944393 — STRYKER STERI-SHIELD SURGICAL APPARELStryker Corp.·1995-08-28
K951623 — TLC SURGICAL GOWNSTlc Tech Lab Clothes, Inc.·1995-08-18
K951984 — WHITE KNIGHT SURGEON'S VESTWhite Knight Healthcare·1995-07-25
K945371 — COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNSStandard Textile Co., Inc.·1995-04-27
K950504 — PERVAL SURGICAL GOWN (MARKETING NAME)Standard Textile Co., Inc.·1995-04-25
K945658 — INTERWOVEN(TM) REUSABLE SURGICAL GOWNBaxter Healthcare Corp·1995-03-22
K944827 — OREX SURGEON'S GOWNThantex Specialties, Inc.·1995-02-28
K944138 — INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIALBaxter Healthcare Corp·1994-12-20
K931562 — GUARDIAN SURGEON'S GOWNSAtkins Healthcare Services·1994-10-07
K940931 — ASEP(TM) PLUS SURGICAL GOWNAngelica Uniform Group, Inc.·1994-07-26
K931456 — SURGICAL DRAPE AND GOWN TRAYCustom Medical Products, Ltd.·1994-07-08
K931144 — STERILE SURGEON'S GOWN, MODIFICATIONAmsco Sterile Recoveries, Inc.·1994-06-10
K934664 — HYDRAGOWNMallinckrodt Group, Inc.·1994-05-24
K940758 — COMPEL SURGICAL GOWNSStandard Textile Co., Inc.·1994-04-22
K934608 — BARRIER FABRIC 450 SURGICAL GOWNJohnson & Johnson Medical, Inc.·1994-04-11
K932694 — KAPPLER PRO/VENT PROCEDURE GOWNKappler, Inc.·1994-03-29
K940069 — DRESSING CHANGE KITMason-Keller Corp.·1994-03-18
K935660 — MEDICOTEX(TRADEMARK APPLICATION PENDING)Itochu International, Inc.·1994-03-07
K930681 — 3M PREVENTION FABRIC SURGICAL GOWN #78XX3M Health Care, Ltd.·1994-02-10
K924055 — N-PACNational Healthcare Linen Service·1993-08-27
K926519 — SURGICAL GOWNCustom Medical Products, Ltd.·1993-08-12
K921151 — O.R./SURGEONS GOWN, ITEM NO. 4951The Sewing Source, Inc.·1993-07-09
K921152 — O.R./SURGEONS GOWN, ITEM NO. 4952The Sewing Source, Inc.·1993-07-09
K921153 — O.R./SURGEONS GOWN, ITEM NO. 4960The Sewing Source, Inc.·1993-07-09
K921154 — O.R./SURGEONS GOWN, ITEM NO. 4962The Sewing Source, Inc.·1993-07-09
K921155 — O.R./SURGEONS GOWN, ITEM NO. 4962The Sewing Source, Inc.·1993-07-09
K921156 — O.R./SURGEONS GOWN, ITEM NO.4941The Sewing Source, Inc.·1993-07-09
K921157 — O.R./SURGEONS GOWN, ITEM NO. 4942The Sewing Source, Inc.·1993-07-09
K921158 — O.R./SURGEONS GOWN, ITEM NO. 4950The Sewing Source, Inc.·1993-07-09
K932003 — N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)National Healthcare Linen Service·1993-06-11
K925715 — RS OPTIGUARD GOWN & DRAPE MATERIALBaxter Healthcare Corp·1993-05-11
K923815 — TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNSLaivan Corp.·1993-03-31
K922753 — COMPEL XTRStandard Textile Co., Inc.·1993-03-09
K921889 — COMPEL O AND RStandard Textile Co., Inc.·1993-02-18
K922949 — SURGICAL GOWNRobert J. Sislian, Inc.·1993-02-16
K920568 — STERILE DISPOSABLE SURGICAL GOWN W/ TOWELBorder Opportunity Saver Systems, Inc.·1992-10-22
K920405 — STERILE SURGEON'S GOWNAmsco Sterile Recoveries, Inc.·1992-08-18
K920996 — BARRIER SURGICAL GOWN WITH SYMETRY FABRICJohnson & Johnson Medical, Inc.·1992-05-31
K920837 — STERILE CONVERTOR SAFECARE GOWN AND DRAPEBaxter Healthcare Corp·1992-05-22
K915502 — MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPESMedline·1992-04-29
K914235 — ASEP SURGEONS GOWNBaxter Interwoven Offsite·1992-04-14
K914839 — COMPEL EStandard Textile Co., Inc.·1992-04-02
K912803 — MSI STERILE BACK SURGICAL GOWN PACK HAND TOWELMedical Sterilization, Inc.·1992-01-10
K914563 — STERILE SUGICAL GOWN PACKAssured Surgical Products, Inc.·1992-01-10
K911508 — MAGNA SURGEONS GOWNSDms Miami, Inc.·1991-06-17
K910515 — FREEDOM MARK III SURGICAL HELMET SYSTEMStackhouse Assoc.·1991-05-06
K911568 — GOWN, OPERATING SURGICALHuntsville Rehabilitation Foundation·1991-04-22
K901536 — STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UVDepuy, Inc.·1990-11-29
K902348 — SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*Futuristic Medical Concepts, Inc.·1990-09-06
K896935 — CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINEBaxter Healthcare Corp·1990-02-16
K894599 — SHIRT, OPERATING, SURGICALMiroz Industries Co.·1989-08-11
K894284 — GOWN, OPERATING, SURGICALMiroz Industries Co.·1989-07-14
K892118 — NON-STERILE MASKS AND CAPSParamount Products, Inc.·1989-04-20
K891211 — SURGICAL GOWN #2001Pro-Safe Professional Linens, Inc.·1989-04-14
K891058 — DENTAL GOWNDispomed, Inc.·1989-04-12
K890474 — SURGICAL GOWNSVictoria Slipper Retail & Mfg., Co.·1989-02-23
K883464 — SURGICAL SHIRTArkansas Lighthouse For the Blind·1988-08-26
K882470 — STERILE DISPOSABLE SURGICAL GOWNSBolden Products, Div. of the Transport Group·1988-08-03
K880382 — KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWNKimberly-Clark Corp.·1988-06-23
K880383 — KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRONKimberly-Clark Corp.·1988-06-23
K880386 — KIMBERLY-CLARK PROTECTIVE SLEEVEKimberly-Clark Corp.·1988-06-23
K872758 — THEATRE GOWNSSmith & Nephew, Inc.·1987-07-31
K871906 — UNIMED SURGEON'S GOWNSUnimed Hospital Supply Corp.·1987-06-09
K864311 — STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)Clinitech, Inc.·1986-11-26
K861600 — SPUNGUARD PLUS SURGICAL GOWNKimberly-Clark Corp.·1986-05-12
K852870 — BARRIER SURGICAL GOWNSurgikos, Inc.·1985-07-23
K851938 — OMNIMED SURGICAL GOWNOmni Intl., Inc.·1985-06-28
K851559 — TURQUOISERoseburg SA·1985-04-30
K850177 — MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN)Matrix Medica, Inc.·1985-02-21
K844703 — GOWNS, SURGICALMedicon, Inc.·1985-01-10
K842958 — BOUNDARY SINGLE-USE OR GOWNProcter & Gamble Mfg. Co.·1984-08-17
K834332 — BOUNDARY SINGLE-USE GOWNSProcter & Gamble Mfg. Co.·1984-05-01
K822925 — BOUNDARY SINGLE-USE GOWNSThe Buckeye Cellulose Corp.·1983-01-12
K821564 — BOUNDARY PROCESS CHANGEThe Buckeye Cellulose Corp.·1982-07-02
K820363 — DISPOSABLE SURGICAL GARMENTSAlphamedix, Inc.·1982-03-08
K820116 — BOUNDARYThe Buckeye Cellulose Corp.·1982-02-23
K813390 — BONDARY SINGLE-USE OR GOWNThe Buckeye Cellulose Corp.·1982-01-05
K811958 — BOUNDARY REINFORCED OR GOWNThe Buckeye Cellulose Corp.·1981-07-27
K802885 — L.A.F. ISOLATION PACKAction Medical Systems, Inc.·1981-01-15
K803158 — IRRADIATED BOUNDARY DEVICESThe Buckeye Cellulose Corp.·1981-01-15
K801025 — ODOR MASKING AGENT FOR CONTENTS OF ALLThe Buckeye Cellulose Corp.·1980-05-30
K800927 — WHITE KNIGHT DISP. STERILE BACK GOWNG.D. Searle and Co.·1980-05-20
K800929 — WHITE KNIGHT SURGICAL PACKG.D. Searle and Co.·1980-05-20
K800124 — ULTRASOFT GOWNMars Mfg Co.·1980-02-05
K792622 — STERILIZATION PROCESS /USE GOWNSProcter & Gamble Mfg. Co.·1980-01-11
K791062 — BOUNDARY SPECIALTY GOWNProcter & Gamble Mfg. Co.·1979-06-20
K781682 — SURGICAL GOWNS & DRAPESKimberly-Clark Corp.·1978-12-20
K781099 — SURGICAL GOWNS AND DRAPESConvertors·1978-08-14
K772182 — SURGICAL GOWN, REINFORCEDSurgikos, Inc.·1977-12-08
K760554 — APPAREL, BARRIER SCRUBSurgikos, Inc.·1976-11-12
K760903 — BARRIER FABRIC 450 SURGICAL GOWNSSurgikos, Inc.·1976-11-11
K760864 — BARRIER FABRIC 450 SPECIALTY GOWNSurgikos, Inc.·1976-11-03
K760237 — GOWN, BOUNDARY SINGLE USE REINFORCEDProcter & Gamble Mfg. Co.·1976-08-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.