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 2011-06-23

SURGICAL PROCEDURE PACKS

Applicant Omnia Spa

K number K110724

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FYA 2011-04-14

3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE

Applicant 3M Company Corp

K number K101468

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FYA 2011-03-11

SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO

Applicant Hangzhou Jincheng Medical Supplier Manufacture Co.

K number K102692

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FYA 2011-02-23

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK

Applicant Microtek Medical, Inc.

K number K102971

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FYA 2011-02-04

BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN

Applicant Bam Corp., Ltd.

K number K093835

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FYA 2011-02-03

NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS

Applicant Gri Medical & Electronic Technology Co., Ltd.

K number K102652

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FYA 2010-12-23

MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS

Applicant Kimberly-Clark Corp.

K number K103406

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FYA 2010-09-27

ATEK SURGICAL GOWNS

Applicant Hangzhou Atek Medical & Textile Co., Ltd.

K number K100971

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FYA 2010-09-03

EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL

Applicant Exact Medical Manufacturing, Inc.

K number K101593

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FYA 2010-03-19

KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100

Applicant Kimberly-Clark Corp.

K number K093115

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FYA 2009-12-17

LAC-MAC INNERBLOC LR SURGICAL GOWNS

Applicant Lac Mac, Ltd.

K number K092344

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FYA 2009-11-12

SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)

Applicant A Plus International, Inc.

K number K093169

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FYA 2009-08-10

MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400

Applicant Kimberly-Clark Corp.

K number K091357

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FYA 2009-05-29

SRI LEVEL II SURGICAL GOWN

Applicant Sri Surgical

K number K090383

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FYA 2009-05-27

PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501

Applicant Promedical Products Co., Ltd.

K number K091097

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FYA 2009-04-24

SKLAR SURGICAL GOWN

Applicant Sklar Corp.

K number K082479

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FYA 2008-11-13

SRI LP GOWN

Applicant Sri/Surgical Express, Inc.

K number K080723

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FYA 2008-11-13

SRI PLR GOWN

Applicant Sri/Surgical Express

K number K080707

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FYA 2008-09-03

ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN

Applicant Kimberly-Clark Corp.

K number K080795

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FYA 2008-04-24

PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A

Applicant Promedical Products Co., Ltd.

K number K080627

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FYA 2007-11-30

STRYKER STRI-SHIELD FLYTE TOGAS

Applicant Stryker Instruments, Instruments Div.

K number K073017

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FYA 2007-05-24

WELMED, INC. SURGICAL GOWNS

Applicant Welmed, Inc.

K number K070431

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FYA 2007-03-23

STRYKER T6 HOODS AND TOGAS

Applicant Stryker Instruments

K number K063005

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FYA 2007-03-14

JOYKEY SURGICAL GOWNS (STERILE)

Applicant Joykey Industryial , Ltd.

K number K062479

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FYA 2007-02-02

STRYKER T4 HYTREL TOGA

Applicant Stryker Instruments, Instruments Div.

K number K070078

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FYA 2007-01-25

MICROTEK MEDICAL SURGICAL GOWN/TOGA

Applicant Microtek Medical, Inc.

K number K062899

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FYA 2006-12-14

MEDLINE STERILE DISPOSABLE SURGICAL GOWNS

Applicant Medline Industries, Inc.

K number K062969

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FYA 2006-08-09

LAC-MAC INNERBLOC O.R. GOWN

Applicant Lac Mac, Ltd.

K number K061491

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FYA 2006-06-05

TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N

Applicant Cardinal Health 200, Inc.

K number K061308

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FYA 2006-05-02

KIMBERLY-CLARK PROCEDURE GOWN

Applicant Kimberly-Clark Corp.

K number K052824

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FYA 2006-03-07

COMPE1 1 -PLY SURGICAL GOWNS

Applicant Standard Textile Co., Inc.

K number K060181

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FYA 2005-11-17

IMC SURGICAL GOWNS

Applicant Intl. Medsurg Connection, Inc.

K number K052550

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FYA 2005-08-02

CARLO SURGICAL GOWN

Applicant Sofilm Technology Co., Ltd.

K number K051426

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FYA 2005-07-01

COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS

Applicant Standard Textile Co., Inc.

K number K041653

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FYA 2005-05-09

BARRIER SURGICAL GOWNS

Applicant Molnlycke Health Care

K number K050786

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FYA 2005-05-05

COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS

Applicant Standard Textile Co., Inc.

K number K041540

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FYA 2005-04-28

COMPEL SURGICAL GOWNS

Applicant Standard Textile Co., Inc.

K number K041539

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FYA 2005-03-16

STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031

Applicant Viasys Medsystems

K number K043004

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FYA 2005-03-16

COMPEL MLR SURGICAL GOWNS

Applicant Standard Textile Co., Inc.

K number K041541

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FYA 2005-03-08

MEDLINE SURGICAL GOWNS

Applicant Medline Industries, Inc.

K number K043585

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FYA 2005-03-08

PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS

Applicant Medline Industries, Inc.

K number K043017

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FYA 2004-12-10

PROMEDICAL SURGICAL GOWNS

Applicant Promedical Products Co., Ltd.

K number K042111

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FYA 2004-10-18

MAXAIR SURGICAL HELMET SYSTEM

Applicant Bio-Medical Devices, Inc.

K number K040485

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FYA 2004-04-27

STRYKER T4 HYTREL ZIPPER TOGA

Applicant Stryker Corp.

K number K040764

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FYA 2004-02-05

INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)

Applicant Lac Mac, Ltd.

K number K032631

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FYA 2003-11-20

DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE

Applicant Deroyal

K number K033057

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FYA 2003-10-15

DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)

Applicant Deroyal

K number K031408

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FYA 2003-09-16

MEDLINE REUSABLE SURGICAL GOWNS (100X)

Applicant Medline Industries, Inc.

K number K031933

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FYA 2003-05-06

LAC-MAC LIMITED INNERBLOC O.R. GOWN

Applicant Lac Mac, Ltd.

K number K030536

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FYA 2003-04-28

DEROYAL GOWNS, STERILE, NON-STERILE

Applicant Deroyal Industries, Inc.

K number K030364

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FYA 2003-01-14

DHS DISPOSABLE HOOD SYSTEM

Applicant Biomet, Inc.

K number K021992

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FYA 2002-11-18

SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN

Applicant Sri/Surgical Express, Inc.

K number K023635

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FYA 2002-11-08

PRIMAGARD SURGICAL GOWNS

Applicant Primeline Medical Products, Inc.

K number K023266

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FYA 2002-10-02

BREATHABLE SURGICAL GOWN

Applicant Allegiance Healthcare Corp.

K number K023167

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FYA 2002-08-01

STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA

Applicant Stryker Instruments

K number K022162

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FYA 2002-05-22

ULTRAGARD IMPERVIOUS REINFORCED GOWN

Applicant Precept Medical Products, Inc.

K number K013846

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FYA 2002-03-18

CONVERTORS SMS POLYOLEFIN GOWN

Applicant Allegiance Healthcare Corp.

K number K020593

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FYA 2001-12-07

MASTER & FRANK SURGICAL GOWNS (STERILE)

Applicant Master & Frank Ent. Co., Ltd.

K number K012186

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FYA 2001-12-03

TRIMAX

Applicant Standard Textile Co., Inc.

K number K012268

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FYA 2001-10-15

MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE

Applicant Mercan AB

K number K012240

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FYA 2001-09-24

BREATHABLE IMPERVIOUS GOWNS

Applicant Allegiance Healthcare Corp.

K number K012984

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FYA 2001-06-07

COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)

Applicant Standard Textile Co., Inc.

K number K010799

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FYA 2001-02-16

MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES

Applicant Medline Industries, Inc.

K number K003755

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FYA 2000-10-26

STACKHOUSE LENS HOOD, MODEL SA-700/FS

Applicant Stackhouse, Inc.

K number K003194

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FYA 2000-08-17

STACKHOUSE LENS HOOD, MODEL SA-700/F

Applicant Stackhouse, Inc.

K number K000605

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FYA 2000-07-11

KLINIDRAPE REINFORCED SURGICAL GOWNS

Applicant Molnlycke Health Care, Inc.

K number K000902

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FYA 2000-07-05

KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION

Applicant Molnlycke Health Care, Inc.

K number K000901

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FYA 2000-04-21

MODIFICATION TO CONVERTORS SURGICAL GOWNS

Applicant Allegiance Healthcare Corp.

K number K001189

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FYA 2000-03-02

MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS

Applicant Medline Industries, Inc.

K number K993170

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FYA 2000-02-18

CONVERTORS SURGICAL GOWNS, STERILE

Applicant Allegiance Healthcare Corp.

K number K994244

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FYA 2000-02-18

MED-GUARD SURGEON'S GOWN

Applicant Kappler USA

K number K992445

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FYA 2000-01-20

GOWN BACK, MODEL 13-403N; 13-404N; 13-405N

Applicant Techstyles

K number K992436

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FYA 1999-12-20

STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE

Applicant Stryker Instruments

K number K994053

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FYA 1999-10-15

STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA

Applicant Stryker Instruments

K number K993148

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FYA 1999-09-22

CONVERTORS SURGICAL GOWNS

Applicant Allegiance Healthcare Corp.

K number K992951

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FYA 1999-08-12

CONVERTORS BREATHABLE SURGICAL GOWNS

Applicant Allegiance Healthcare Corp.

K number K992514

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FYA 1999-04-16

CONVERTORS SURGICAL GOWNS

Applicant Allegiance Healthcare Corp.

K number K991034

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FYA 1999-04-13

BARRIER SURGICAL GOWNS

Applicant Johnson & Johnson Medical, Div. of Ethicon, Inc.

K number K990395

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FYA 1999-04-02

STERILE BACK SURGICAL GOWN WITH HAND TOWEL

Applicant Medical Sterilization, Inc.

K number K984422

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FYA 1999-01-14

ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN

Applicant Encompass Group, LLC

K number K982058

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FYA 1998-12-14

MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES

Applicant Medline Industries, Inc.

K number K982694

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FYA 1998-11-30

ROTECNO 2000 SURGICAL GOWN

Applicant Encompass Group, LLC

K number K982059

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FYA 1998-10-28

MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS

Applicant Medline Industries, Inc.

K number K982693

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FYA 1998-07-10

MICROCOOL SURGICAL GOWN

Applicant Kimberly-Clark Corp.

K number K981393

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FYA 1998-05-15

MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK

Applicant Medcom Laundry Service, Inc.

K number K981073

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FYA 1997-12-04

GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)

Applicant Customed, Inc.

K number K971920

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FYA 1997-10-21

PROVISION SURGICAL HELMET SYSTEM

Applicant Depuy, Inc.

K number K972832

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FYA 1997-10-20

ULTRASOUND TRANSDUCER DRAPE

Applicant Protek Medical Products, Inc.

K number K970893

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FYA 1997-02-27

BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN

Applicant Bemiss-Jason Corp., Triad Medical Div.

K number K962666

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FYA 1997-01-30

P1OP2B OR P1O92T

Applicant Kay Borch A/S

K number K954674

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FYA 1996-11-20

COOL-ZONE

Applicant Kappler USA

K number K963809

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FYA 1996-10-28

CONVERTORS POLYOLEFIN FABRIC GOWNS

Applicant Baxter Healthcare Corp

K number K961341

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FYA 1996-09-17

DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL

Applicant Depuy, Inc.

K number K961239

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FYA 1996-08-30

ROBISON & SMITH SURGICAL PACKS

Applicant Robison & Smith, Inc.

K number K955586

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FYA 1996-08-23

OREX SURGEON'S VEST

Applicant Thantex Specialties, Inc.

K number K961083

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FYA 1996-07-12

EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP

Applicant Safetec of America, Inc.

K number K960073

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FYA 1995-09-05

MERTEX-PLUS O.R./SURGEONS GOWN

Applicant Mercana Industries , Ltd.

K number K953251

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FYA 1995-08-28

STRYKER STERI-SHIELD SURGICAL APPAREL

Applicant Stryker Corp.

K number K944393

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FYA 1995-08-18

TLC SURGICAL GOWNS

Applicant Tlc Tech Lab Clothes, Inc.

K number K951623

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FYA 1995-07-25

WHITE KNIGHT SURGEON'S VEST

Applicant White Knight Healthcare

K number K951984

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