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.

Mask, Surgical

FDA product code FXX · 601 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4040
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-16 – 2026-03-18

FXX 2012-12-21

FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK

Applicant Tiger Medical Products, Ltd.

K number K122717

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FXX 2011-10-20

KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL

Applicant Kimberly-Clark

K number K111402

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FXX 2011-10-06

CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS

Applicant Crosstex International, Inc.

K number K111343

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FXX 2011-09-16

SURGICAL MASKS

Applicant Shanghai Neo-Medical Import & Export Co., Ltd.

K number K111559

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FXX 2011-08-05

SURGICAL FACE MASK; SURGICAL FACE MASK

Applicant Angeline Group , Ltd.

K number K110027

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FXX 2011-04-29

KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS

Applicant Kimberly-Clark Corp.

K number K110455

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FXX 2011-01-25

TIGER FLAT SURGICAL MASK

Applicant Tiger Medical Products, Ltd.

K number K102713

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FXX 2010-12-23

CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE

Applicant Crosstex International, Inc.

K number K103303

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FXX 2010-09-10

SURGICAL FACE MASK

Applicant Epard Protective Products, Ltd.

K number K093901

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FXX 2010-08-16

IMC SURGICAL FACE MASK

Applicant International Medsurg Connection

K number K100846

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FXX 2010-08-09

WELLMIEN SURGICAL MASK

Applicant Wellmien (Suzhou) Import & Export Trading Co., Ltd.

K number K101000

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FXX 2010-07-14

MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)

Applicant H&H Research Company

K number K093179

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FXX 2010-06-14

TIDI FACEMASK

Applicant Tidi Products,Llc

K number K100800

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FXX 2010-02-23

TIDI FACEMASK

Applicant Tidi Products,Llc

K number K092580

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FXX 2009-09-25

PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70

Applicant Primed Medical Products, Inc.

K number K092012

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FXX 2008-10-16

CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR

Applicant Crosstex International

K number K082258

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FXX 2008-08-11

PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS

Applicant Primed Medical Products, Inc.

K number K081633

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FXX 2007-03-26

DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE

Applicant Dukal Corp.

K number K070407

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FXX 2007-03-21

SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP

Applicant Modern Healthcare Corp.

K number K063043

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FXX 2006-09-15

DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560

Applicant Dukal Corp.

K number K061864

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FXX 2006-08-14

PRESTIGE AMERITECH FACE MASK

Applicant Prestige Ameritech

K number K061716

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FXX 2006-05-25

SURGICAL FACE MASK

Applicant Hong YA Non-Woven Products Co., Ltd.

K number K060776

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FXX 2005-10-26

SURGICAL FACE MASK

Applicant China Surgical Dressings Center Co., Ltd.

K number K050689

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FXX 2005-09-20

NON-STERILE SURGICAL MASK

Applicant A.R. Medicom, Inc.

K number K051291

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FXX 2005-02-16

SURGICAL FACE MASK

Applicant Hong YA Non-Woven Products Co., Ltd.

K number K043199

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FXX 2004-12-17

PROTECTION PLUS EARLOOP PROCEDURE MASK

Applicant Safety-Med Products, Inc.

K number K042654

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FXX 2004-12-01

ULTRADENT CARBON MASK - UPI #342

Applicant Medspring Group, Incorporated

K number K041047

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FXX 2004-06-07

VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS

Applicant Valumax Intl., Inc.

K number K040333

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FXX 2004-04-26

SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN

Applicant Tucker & Associates

K number K022256

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FXX 2004-02-20

EARLOOP PROCEDURE MASK

Applicant Medipack Medical Packaging Mfg. Co.

K number K034015

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FXX 2003-07-24

MEGATECH SCIENTIFIC FACE MASK

Applicant Megatech Scientific Pte, Ltd.

K number K030239

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FXX 2003-06-19

SOLUTION FACE MASKS

Applicant A Plus International, Inc.

K number K031353

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FXX 2003-06-10

WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD

Applicant Winner Industries (Shenzhen) Co., Ltd.

K number K023755

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FXX 2003-03-05

DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR

Applicant Creative Contract (M) Sdn Bhd

K number K021546

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FXX 2003-03-05

DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS

Applicant Creative Contract (M) Sdn Bhd

K number K021539

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FXX 2003-03-05

DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)

Applicant Creative Contract (M) Sdn Bhd

K number K021533

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FXX 2002-04-16

PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM

Applicant Primeline Medical Products, Inc.

K number K021076

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FXX 2002-01-22

CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX

Applicant Crosstex Intl.

K number K012602

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FXX 2001-06-22

PROCEDURE MASKS: PM4-301 AND PM4-304

Applicant Primeline Medical Products, Inc.

K number K011789

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FXX 2001-04-03

WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)

Applicant White Knight Healthcare, Inc.

K number K001892

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FXX 2001-04-02

WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)

Applicant White Knight Healthcare, Inc.

K number K001997

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FXX 2001-04-02

WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)

Applicant White Knight Healthcare, Inc.

K number K001893

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FXX 2000-09-08

PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306

Applicant Primeline Medical Products, Inc.

K number K001951

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FXX 2000-01-28

HENRY SCHEIN SURGICAL MASK

Applicant Mitsui Textile Corp.

K number K992604

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FXX 1999-08-23

MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD

Applicant Medline Industries, Inc.

K number K991559

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FXX 1999-07-12

EARLOOP FACE MASK

Applicant Shuenn Bao Shing Corp.

K number K990719

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FXX 1999-04-09

TOP WHOLESOME FACE MASK

Applicant Top Wholesome Enterprise Co., Ltd.

K number K984389

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FXX 1998-05-28

ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)

Applicant Cypress Medical Products, Ltd.

K number K972849

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FXX 1998-02-26

ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)

Applicant Cypress Medical Products, Ltd.

K number K972883

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FXX 1997-09-03

FACE MASK, SURGICAL MASK, NON-STERILE

Applicant Tucker & Associates

K number K970835

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FXX 1997-07-28

FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)

Applicant Berkley Medical Resources, Inc.

K number K971744

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FXX 1997-06-27

DEFEND FLUID RESISTANT PLEATED MASK

Applicant Carl Parker Associates, Inc.

K number K971130

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FXX 1997-05-06

DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS

Applicant Depuy, Inc.

K number K964114

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FXX 1997-03-27

EKONIC DENTAL/MEDICAL MASK (MD 610)

Applicant Ekonic Company, Ltd.

K number K970440

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FXX 1997-03-11

MEDLINE ADMISSION KITS

Applicant Medline Industries, Inc.

K number K965107

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FXX 1997-03-10

3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE

Applicant Minnesota Mining and Mfg. Co.

K number K965043

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FXX 1997-03-03

PROCEDURE SPECIFIC KITS

Applicant Sage Products, Inc.

K number K964168

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FXX 1997-02-25

MASK SURGICAL

Applicant The Innovative Approach, Corp.

K number K963568

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FXX 1997-02-14

AMSEAL SURGICAL FACE MASK

Applicant American Seal Co.

K number K964358

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FXX 1997-02-07

RACAL N95 RESIRATOR

Applicant Racal Filter Technologies, Inc.

K number K964723

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FXX 1997-02-07

DELTA N95 RESPIRATOR

Applicant Racal Filter Technologies, Inc.

K number K964722

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FXX 1997-01-27

COMPLEAT SURGICAL MASK

Applicant Carl Parker Associates, Inc.

K number K962654

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FXX 1997-01-03

N95 FILTERING FACEPIECE

Applicant Survivair, Inc.

K number K962443

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FXX 1996-10-07

2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD

Applicant Berkley Medical Resources, Inc.

K number K962286

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FXX 1996-07-25

BODILY FLUID DISPOSAL KIT

Applicant Transidyne General Corp.

K number K961217

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FXX 1996-07-12

STS SHIELD WITH MASK

Applicant Innovative Outsourcing Solutions

K number K961402

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FXX 1996-07-12

EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS

Applicant Safetec of America, Inc.

K number K960048

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FXX 1996-05-01

3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95

Applicant 3M Company

K number K955382

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FXX 1996-04-25

FLUID REISISTANT EYESHIELD MASK

Applicant American Threshold Healthcare

K number K955557

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FXX 1996-04-25

FLUID RESISTANT MASK

Applicant American Threshold Healthcare

K number K955556

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FXX 1996-04-22

SURGICAL MASK (NON-STERILE)

Applicant United Medical Ent., Inc.

K number K955513

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FXX 1996-01-26

GLOBAL HEALTHCARE FACE MASK

Applicant Global Healthcare, Inc.

K number K953754

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FXX 1996-01-23

BODY FLUID BARRIER KIT

Applicant Lhb Industries, Inc.

K number K952961

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FXX 1995-12-11

BLOODBORNE PATHOGEN KIT

Applicant Certified Safety Mfg., Inc.

K number K953102

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FXX 1995-10-12

OVAL SURGICAL FACE MASK

Applicant Oval Industries, Ltd.

K number K951913

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FXX 1995-09-27

EZ-PERSONAL PROTECTION KIT

Applicant Safetec of America, Inc.

K number K952962

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FXX 1995-06-28

NORTH BLOODBORNE PATHOGEN RESPONSE KIT

Applicant North Safety Products

K number K950554

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FXX 1995-06-09

EMERGENCY RESPONSE SAFETY KIT

Applicant Ani Safety, Inc.

K number K946001

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FXX 1995-06-02

PENTAX FACE MASK

Applicant Pentax Precision Instrument Corp.

K number K933683

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FXX 1995-03-22

INTEC EXTENDED EYE SHIELD WITH MASK

Applicant Intec Industries, Inc.

K number K946343

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FXX 1994-12-15

BODILY FLUID DISPOSAL KIT

Applicant Clinical Resources, Inc.

K number K944880

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FXX 1994-11-02

BODY FLUIDS BARRIER KIT

Applicant Ani Safety, Inc.

K number K944545

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FXX 1994-11-02

BUSSE ISOLATION AND PROCEDURAL MASKS

Applicant Busse Hospital Disposables, Inc.

K number K940720

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FXX 1994-10-18

PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069

Applicant Protectaide, Inc.

K number K942476

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FXX 1994-10-18

PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351

Applicant Protectaide, Inc.

K number K942475

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FXX 1994-10-18

PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000

Applicant Protectaide, Inc.

K number K942474

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FXX 1994-10-18

PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592

Applicant Protectaide, Inc.

K number K942473

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FXX 1994-10-18

PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123

Applicant Protectaide, Inc.

K number K942472

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FXX 1994-10-18

PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777

Applicant Protectaide, Inc.

K number K942471

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FXX 1994-10-18

PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315

Applicant Protectaide, Inc.

K number K942470

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FXX 1994-06-17

SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD

Applicant Bam Corp., Ltd.

K number K933748

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FXX 1994-05-23

3M SURGICAL MASK WITH FACE SHEILD

Applicant 3M Company

K number K940707

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FXX 1994-05-03

TECNOL PCM 2000

Applicant Tecnol Medical Products, Inc.

K number K932834

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FXX 1994-05-02

DISPOSABLE SURGICAL MASK (MODIFIED)

Applicant Bam Corp., Ltd.

K number K931580

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FXX 1994-04-29

EYSOTEK

Applicant Isotech Corp.

K number K932133

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FXX 1994-04-29

EYSOTEK

Applicant Isotech Corp.

K number K932132

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FXX 1994-04-15

FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR

Applicant Tecnol Medical Products, Inc.

K number K932137

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FXX 1994-04-13

FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD

Applicant Mid America Medical, Inc.

K number K934974

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FXX 1994-03-28

DUALGARD FACE SHIELD

Applicant White Knight Healthcare

K number K934969

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FXX 1994-03-28

BARRIER LASER PLUS FACE MASK

Applicant Johnson & Johnson Medical, Inc.

K number K934194

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