Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Gown, Surgical

FDA product code FYA · 290 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4040
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-11 – 2026-08-26

FYA 1995-04-27

COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS

Applicant Standard Textile Co., Inc.

K number K945371

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FYA 1995-04-25

PERVAL SURGICAL GOWN (MARKETING NAME)

Applicant Standard Textile Co., Inc.

K number K950504

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FYA 1995-03-22

INTERWOVEN(TM) REUSABLE SURGICAL GOWN

Applicant Baxter Healthcare Corp

K number K945658

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FYA 1995-02-28

OREX SURGEON'S GOWN

Applicant Thantex Specialties, Inc.

K number K944827

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FYA 1994-12-20

INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL

Applicant Baxter Healthcare Corp

K number K944138

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FYA 1994-10-07

GUARDIAN SURGEON'S GOWNS

Applicant Atkins Healthcare Services

K number K931562

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FYA 1994-07-26

ASEP(TM) PLUS SURGICAL GOWN

Applicant Angelica Uniform Group, Inc.

K number K940931

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FYA 1994-07-08

SURGICAL DRAPE AND GOWN TRAY

Applicant Custom Medical Products, Ltd.

K number K931456

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FYA 1994-06-10

STERILE SURGEON'S GOWN, MODIFICATION

Applicant Amsco Sterile Recoveries, Inc.

K number K931144

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FYA 1994-05-24

HYDRAGOWN

Applicant Mallinckrodt Group, Inc.

K number K934664

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FYA 1994-04-22

COMPEL SURGICAL GOWNS

Applicant Standard Textile Co., Inc.

K number K940758

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FYA 1994-04-11

BARRIER FABRIC 450 SURGICAL GOWN

Applicant Johnson & Johnson Medical, Inc.

K number K934608

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FYA 1994-03-29

KAPPLER PRO/VENT PROCEDURE GOWN

Applicant Kappler, Inc.

K number K932694

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FYA 1994-03-18

DRESSING CHANGE KIT

Applicant Mason-Keller Corp.

K number K940069

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FYA 1994-03-07

MEDICOTEX(TRADEMARK APPLICATION PENDING)

Applicant Itochu International, Inc.

K number K935660

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FYA 1994-02-10

3M PREVENTION FABRIC SURGICAL GOWN #78XX

Applicant 3M Health Care, Ltd.

K number K930681

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FYA 1993-08-27

N-PAC

Applicant National Healthcare Linen Service

K number K924055

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FYA 1993-08-12

SURGICAL GOWN

Applicant Custom Medical Products, Ltd.

K number K926519

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FYA 1993-07-09

O.R./SURGEONS GOWN, ITEM NO. 4950

Applicant The Sewing Source, Inc.

K number K921158

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FYA 1993-07-09

O.R./SURGEONS GOWN, ITEM NO. 4942

Applicant The Sewing Source, Inc.

K number K921157

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FYA 1993-07-09

O.R./SURGEONS GOWN, ITEM NO.4941

Applicant The Sewing Source, Inc.

K number K921156

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FYA 1993-07-09

O.R./SURGEONS GOWN, ITEM NO. 4962

Applicant The Sewing Source, Inc.

K number K921155

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FYA 1993-07-09

O.R./SURGEONS GOWN, ITEM NO. 4962

Applicant The Sewing Source, Inc.

K number K921154

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FYA 1993-07-09

O.R./SURGEONS GOWN, ITEM NO. 4960

Applicant The Sewing Source, Inc.

K number K921153

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FYA 1993-07-09

O.R./SURGEONS GOWN, ITEM NO. 4952

Applicant The Sewing Source, Inc.

K number K921152

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FYA 1993-07-09

O.R./SURGEONS GOWN, ITEM NO. 4951

Applicant The Sewing Source, Inc.

K number K921151

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FYA 1993-06-11

N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)

Applicant National Healthcare Linen Service

K number K932003

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FYA 1993-05-11

RS OPTIGUARD GOWN & DRAPE MATERIAL

Applicant Baxter Healthcare Corp

K number K925715

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FYA 1993-03-31

TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS

Applicant Laivan Corp.

K number K923815

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FYA 1993-03-09

COMPEL XTR

Applicant Standard Textile Co., Inc.

K number K922753

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FYA 1993-02-18

COMPEL O AND R

Applicant Standard Textile Co., Inc.

K number K921889

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FYA 1993-02-16

SURGICAL GOWN

Applicant Robert J. Sislian, Inc.

K number K922949

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FYA 1992-10-22

STERILE DISPOSABLE SURGICAL GOWN W/ TOWEL

Applicant Border Opportunity Saver Systems, Inc.

K number K920568

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FYA 1992-08-18

STERILE SURGEON'S GOWN

Applicant Amsco Sterile Recoveries, Inc.

K number K920405

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FYA 1992-05-31

BARRIER SURGICAL GOWN WITH SYMETRY FABRIC

Applicant Johnson & Johnson Medical, Inc.

K number K920996

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FYA 1992-05-22

STERILE CONVERTOR SAFECARE GOWN AND DRAPE

Applicant Baxter Healthcare Corp

K number K920837

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FYA 1992-04-29

MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES

Applicant Medline

K number K915502

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FYA 1992-04-14

ASEP SURGEONS GOWN

Applicant Baxter Interwoven Offsite

K number K914235

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FYA 1992-04-02

COMPEL E

Applicant Standard Textile Co., Inc.

K number K914839

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FYA 1992-01-10

STERILE SUGICAL GOWN PACK

Applicant Assured Surgical Products, Inc.

K number K914563

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FYA 1992-01-10

MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL

Applicant Medical Sterilization, Inc.

K number K912803

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FYA 1991-06-17

MAGNA SURGEONS GOWNS

Applicant Dms Miami, Inc.

K number K911508

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FYA 1991-05-06

FREEDOM MARK III SURGICAL HELMET SYSTEM

Applicant Stackhouse Assoc.

K number K910515

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FYA 1991-04-22

GOWN, OPERATING SURGICAL

Applicant Huntsville Rehabilitation Foundation

K number K911568

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FYA 1990-11-29

STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV

Applicant Depuy, Inc.

K number K901536

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FYA 1990-09-06

SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*

Applicant Futuristic Medical Concepts, Inc.

K number K902348

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FYA 1990-02-16

CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE

Applicant Baxter Healthcare Corp

K number K896935

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FYA 1989-08-11

SHIRT, OPERATING, SURGICAL

Applicant Miroz Industries Co.

K number K894599

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FYA 1989-07-14

GOWN, OPERATING, SURGICAL

Applicant Miroz Industries Co.

K number K894284

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FYA 1989-04-20

NON-STERILE MASKS AND CAPS

Applicant Paramount Products, Inc.

K number K892118

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FYA 1989-04-14

SURGICAL GOWN #2001

Applicant Pro-Safe Professional Linens, Inc.

K number K891211

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FYA 1989-04-12

DENTAL GOWN

Applicant Dispomed, Inc.

K number K891058

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FYA 1989-02-23

SURGICAL GOWNS

Applicant Victoria Slipper Retail & Mfg., Co.

K number K890474

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FYA 1988-08-26

SURGICAL SHIRT

Applicant Arkansas Lighthouse For the Blind

K number K883464

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FYA 1988-08-03

STERILE DISPOSABLE SURGICAL GOWNS

Applicant Bolden Products, Div. of the Transport Group

K number K882470

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FYA 1988-06-23

KIMBERLY-CLARK PROTECTIVE SLEEVE

Applicant Kimberly-Clark Corp.

K number K880386

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FYA 1988-06-23

KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON

Applicant Kimberly-Clark Corp.

K number K880383

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FYA 1988-06-23

KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN

Applicant Kimberly-Clark Corp.

K number K880382

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FYA 1987-07-31

THEATRE GOWNS

Applicant Smith & Nephew, Inc.

K number K872758

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FYA 1987-06-09

UNIMED SURGEON'S GOWNS

Applicant Unimed Hospital Supply Corp.

K number K871906

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FYA 1986-11-26

STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)

Applicant Clinitech, Inc.

K number K864311

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FYA 1986-05-12

SPUNGUARD PLUS SURGICAL GOWN

Applicant Kimberly-Clark Corp.

K number K861600

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FYA 1985-07-23

BARRIER SURGICAL GOWN

Applicant Surgikos, Inc.

K number K852870

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FYA 1985-06-28

OMNIMED SURGICAL GOWN

Applicant Omni Intl., Inc.

K number K851938

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FYA 1985-04-30

TURQUOISE

Applicant Roseburg SA

K number K851559

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FYA 1985-02-21

MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN)

Applicant Matrix Medica, Inc.

K number K850177

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FYA 1985-01-10

GOWNS, SURGICAL

Applicant Medicon, Inc.

K number K844703

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FYA 1984-08-17

BOUNDARY SINGLE-USE OR GOWN

Applicant Procter & Gamble Mfg. Co.

K number K842958

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FYA 1984-05-01

BOUNDARY SINGLE-USE GOWNS

Applicant Procter & Gamble Mfg. Co.

K number K834332

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FYA 1983-01-12

BOUNDARY SINGLE-USE GOWNS

Applicant The Buckeye Cellulose Corp.

K number K822925

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FYA 1982-07-02

BOUNDARY PROCESS CHANGE

Applicant The Buckeye Cellulose Corp.

K number K821564

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FYA 1982-03-08

DISPOSABLE SURGICAL GARMENTS

Applicant Alphamedix, Inc.

K number K820363

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FYA 1982-02-23

BOUNDARY

Applicant The Buckeye Cellulose Corp.

K number K820116

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FYA 1982-01-05

BONDARY SINGLE-USE OR GOWN

Applicant The Buckeye Cellulose Corp.

K number K813390

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FYA 1981-07-27

BOUNDARY REINFORCED OR GOWN

Applicant The Buckeye Cellulose Corp.

K number K811958

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FYA 1981-01-15

IRRADIATED BOUNDARY DEVICES

Applicant The Buckeye Cellulose Corp.

K number K803158

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FYA 1981-01-15

L.A.F. ISOLATION PACK

Applicant Action Medical Systems, Inc.

K number K802885

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FYA 1980-05-30

ODOR MASKING AGENT FOR CONTENTS OF ALL

Applicant The Buckeye Cellulose Corp.

K number K801025

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FYA 1980-05-20

WHITE KNIGHT SURGICAL PACK

Applicant G.D. Searle and Co.

K number K800929

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FYA 1980-05-20

WHITE KNIGHT DISP. STERILE BACK GOWN

Applicant G.D. Searle and Co.

K number K800927

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FYA 1980-02-05

ULTRASOFT GOWN

Applicant Mars Mfg Co.

K number K800124

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FYA 1980-01-11

STERILIZATION PROCESS /USE GOWNS

Applicant Procter & Gamble Mfg. Co.

K number K792622

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FYA 1979-06-20

BOUNDARY SPECIALTY GOWN

Applicant Procter & Gamble Mfg. Co.

K number K791062

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FYA 1978-12-20

SURGICAL GOWNS & DRAPES

Applicant Kimberly-Clark Corp.

K number K781682

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FYA 1978-08-14

SURGICAL GOWNS AND DRAPES

Applicant Convertors

K number K781099

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FYA 1977-12-08

SURGICAL GOWN, REINFORCED

Applicant Surgikos, Inc.

K number K772182

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FYA 1976-11-12

APPAREL, BARRIER SCRUB

Applicant Surgikos, Inc.

K number K760554

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FYA 1976-11-11

BARRIER FABRIC 450 SURGICAL GOWNS

Applicant Surgikos, Inc.

K number K760903

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FYA 1976-11-03

BARRIER FABRIC 450 SPECIALTY GOWN

Applicant Surgikos, Inc.

K number K760864

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FYA 1976-08-11

GOWN, BOUNDARY SINGLE USE REINFORCED

Applicant Procter & Gamble Mfg. Co.

K number K760237

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