Accessory, Surgical Apparel

FDA product code LYU · 56 cleared devices

Class 1 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: 1988-10-11 – 2001-06-22

LYU 2001-06-22

STRYKER T4 HYTREL (R) TOGAS

Applicant Stryker Corp.

K number K011755

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LYU 1997-08-27

NURSES BOUFFANT CAP

Applicant Copioumed Intl., Inc.

K number K965237

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LYU 1997-07-10

FAR-EAST BOUFFANT CAPS

Applicant Far East Science & Technology Development Co., Ltd.

K number K970988

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LYU 1997-02-25

DISPOSABLE APRON

Applicant Instrument Makar, Inc.

K number K964364

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LYU 1996-08-09

DEPUY DISPOSABLE FILTER/HOOD

Applicant Depuy, Inc.

K number K961791

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LYU 1996-07-25

AMMI MAGNI-GUARD

Applicant American Medical Mfg., Inc.

K number K961454

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LYU 1996-03-19

SLOAN STA-DRI PANT PROTECTOR

Applicant Sloan Corp.

K number K945302

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LYU 1995-12-28

ULTRAFIT LINERS

Applicant Stahmer Weston Scientific

K number K954314

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LYU 1995-10-16

I-SPOUSE

Applicant Products For Medicine

K number K953089

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LYU 1995-08-24

SPLASH ASSIST

Applicant Innovative Outsourcing Solutions

K number K952303

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LYU 1995-08-07

ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS

Applicant Thantex Specialties, Inc.

K number K942200

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LYU 1995-07-31

SLOAN STA-DRI BOOTLEG LEGGING

Applicant Sloan Corp.

K number K944276

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LYU 1995-07-31

SLOAN STA-DRI SURGICAL JUMPSUIT

Applicant Sloan Corp.

K number K944118

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LYU 1995-06-28

INTEC FULL FACE SHIELD

Applicant Intec Industries, Inc.

K number K946003

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LYU 1995-06-08

INCASE EXTENSIBLE BAG--NON-STERILE

Applicant Alpha Surgical, Inc.

K number K951420

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LYU 1995-04-10

CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER

Applicant Wells Lamont Corp.

K number K944763

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LYU 1995-02-28

OP-D-OP II

Applicant Op-D-Op Visor Shields, Inc.

K number K945098

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LYU 1995-02-23

MAKAR FULL AND HALF FACE SHIELD

Applicant Instrument Makar, Inc.

K number K942828

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LYU 1994-11-28

MONOGARD FACE SHIELD

Applicant White Knight Healthcare

K number K943809

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LYU 1994-09-26

BOUFFANT CAP

Applicant Derekduck Industries Corp.

K number K940228

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LYU 1994-09-26

SHOE COVER

Applicant Derekduck Industries Corp.

K number K940226

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LYU 1994-09-06

BODY BOOT

Applicant Mark-Clark

K number K940723

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LYU 1994-07-19

SPLASH MASK

Applicant Incon Diversified Industries, Inc.

K number K941932

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LYU 1994-07-08

FACE-IT SHIELD

Applicant Onyx Medical Corp.

K number K942022

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LYU 1994-06-24

DERMAL GLOVES

Applicant George Glove Company, Inc.

K number K932953

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LYU 1994-05-12

NYLON LINER GLOVES

Applicant Wells Lamont Corp.

K number K940274

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LYU 1994-04-20

KACEY DISPOSABLE GLOVE LINER

Applicant K & C Medical, Inc.

K number K935158

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LYU 1994-04-13

MOORE SECURE CAP

Applicant Kerma Medical Products, Inc.

K number K931042

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LYU 1994-04-06

SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD)

Applicant Cabot Safety Corp.

K number K935723

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LYU 1994-03-09

TECNOL SPLASHGUARD

Applicant Tecnol Medical Products, Inc.

K number K934842

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LYU 1994-02-14

PROCEL(TM) DERMALINER GLOVE

Applicant W. L. Gore & Associates, Inc.

K number K931094

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LYU 1994-02-01

AGAFAR FACE SHIELD

Applicant Infection Control Products, Inc.

K number K935779

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LYU 1994-01-21

ISOLAIR 2 FULL FACE SPLASH GUARD

Applicant Louis M. Gerson Co., Inc.

K number K931288

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LYU 1993-08-18

ACTION MEDTEK FACE SHIELD

Applicant Action Eyewear Corp.

K number K926438

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LYU 1993-07-23

CATALOG NUMBER 111 (FACESHIELD)

Applicant Ansley Medical Products, Inc.

K number K925290

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LYU 1993-07-09

ULTRATUFF CUT RESISTANT GLOVE LINER

Applicant Baxter Healthcare Corp

K number K925628

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LYU 1993-06-15

WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS

Applicant Wells Lamont Corp.

K number K922407

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LYU 1993-05-07

MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE

Applicant Medical Armor Corp.

K number K923229

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LYU 1992-10-15

GUARDALL SHIELD

Applicant Anago, Inc.

K number K915415

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LYU 1992-02-03

FINGGUARD

Applicant Allied Signal, Inc.

K number K915056

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LYU 1991-12-02

REPEL(TM) LITE CUT RESISTANT GLOVE LINERS

Applicant Depuy-Raynham

K number K914077

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LYU 1991-10-08

MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV

Applicant Medical Armor Corp.

K number K912737

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LYU 1991-10-04

MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO

Applicant Medical Armor Corp.

K number K912457

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LYU 1991-06-27

NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER

Applicant Lovell-Schenck, Inc.

K number K910890

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LYU 1991-06-07

OP-D-OP VISOR SHIELDS

Applicant Op-D-Op, Inc.

K number K911742

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LYU 1991-01-08

PARADERM(TM) SURGEON'S GLOVE ACCESSORY

Applicant Lovell-Schenck, Inc.

K number K904903

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LYU 1990-09-07

SURGICAL COTTON GLOVES

Applicant Allo Pro Corp.

K number K900425

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LYU 1990-07-27

CUT RESISTANT GLOVE LINER

Applicant Biomet, Inc.

K number K902633

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LYU 1990-07-10

PHYSICIAN BARRIER GLOVE, SURGICAL

Applicant Dynamic Marketing Ent.

K number K901221

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LYU 1990-05-16

MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE

Applicant Aor-Sullivan

K number K902016

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LYU 1990-03-01

REPEL SURGICAL GLOVE LINERS

Applicant Depuy-Raynham

K number K900310

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LYU 1989-08-11

STERILE HAND COVER

Applicant Sage Products, Inc.

K number K894064

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LYU 1989-08-02

CYSTO APRONS IN VARIOUS SIZES

Applicant Bemiss Jason Corp.

K number K893842

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LYU 1989-06-01

AOR-SULLIVAN PROTECTIVE OVERGLOVE

Applicant Aor-Sullivan

K number K893118

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LYU 1988-10-11

PROTECT-AIDS AUTOPSY UNDERGLOVE

Applicant Medical Armor Corp.

K number K880440

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LYU 1988-10-11

PROTECT-AIDS UNDERGLOVE

Applicant Medical Armor Corp.

K number K880439

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