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 1994-02-10

BARRIER EXTRA PROTECTION PLUS FACE MASK

Applicant Johnson & Johnson Medical, Inc.

K number K920108

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FXX 1994-02-03

ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS

Applicant Louis M. Gerson Co., Inc.

K number K925185

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FXX 1993-11-30

BUFFALO FILTER SURGICAL MASK

Applicant Buffalo Filter Co., Inc.

K number K930067

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FXX 1993-01-27

TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK

Applicant Tecnol Medical Products, Inc.

K number K920162

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FXX 1993-01-27

TECNOL FLUIDSHIELD INFECTION CONTROL MASK

Applicant Tecnol Medical Products, Inc.

K number K915817

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FXX 1992-11-16

GERSON ISOLAIR APR PARTICULATE SURGICAL MASK

Applicant Louis M. Gerson Co., Inc.

K number K922507

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FXX 1992-10-23

SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509

Applicant Splash Shield, Inc.

K number K922716

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FXX 1992-10-05

TECNOL INFECTION CONTROL MASK

Applicant Tecnol Medical Products, Inc.

K number K920203

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FXX 1992-09-01

CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER

Applicant Trinity Laboratories, Inc.

K number K920846

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FXX 1992-04-28

PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001

Applicant Phoenix Steri-Tech, Inc.

K number K920682

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FXX 1992-02-14

SURGICAL APPAREL

Applicant W. L. Gore & Associates, Inc.

K number K914832

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FXX 1991-12-19

MASK, SURGICAL, DISPOSABLE

Applicant Industries For the Blind

K number K914412

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FXX 1991-11-07

RELIABLE CONE STYLE FACE MASK

Applicant Anago, Inc.

K number K913558

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FXX 1991-08-29

MASK, SURGICAL APPAREL

Applicant Thai Hospital Products Co., Ltd.

K number K911334

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FXX 1991-08-23

MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS

Applicant Tecnol New Jersey Wound Care, Inc.

K number K913043

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FXX 1991-07-12

FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK

Applicant Tecnol New Jersey Wound Care, Inc.

K number K911891

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FXX 1991-07-08

FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS

Applicant Tecnol New Jersey Wound Care, Inc.

K number K911907

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FXX 1991-04-29

BARRIER* EXTRA PROTECTION PLUS FACE MASK

Applicant Johnson & Johnson Medical, Inc.

K number K910557

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FXX 1991-03-20

TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK

Applicant 3M Company

K number K910110

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FXX 1991-03-06

ANTI-FOR SURGICAL FACE MASK

Applicant Anago, Inc.

K number K905865

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FXX 1991-03-04

3M BRAND EAR LOOP FACE MASK, 2000F

Applicant 3M Company

K number K910182

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FXX 1991-03-04

SURGICAL FACE MASK

Applicant Anago, Inc.

K number K905749

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FXX 1991-02-21

SURGICAL MASK

Applicant Lancaster County Blind Assoc.

K number K905209

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FXX 1990-10-23

MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493

Applicant Pennsylvania Association For the Blind

K number K903486

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FXX 1990-09-05

THE PROTECTOR II, LASER SURGICAL MASK

Applicant Anago, Inc.

K number K902547

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FXX 1990-09-05

THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK

Applicant Anago, Inc.

K number K902546

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FXX 1990-05-14

DRESSING CHANGE KIT

Applicant Healthdyne Cardiovascular, Inc.

K number K900665

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FXX 1990-03-08

MASKS SURGICAL DENTAL

Applicant Kab Gloves Unltd.

K number K900088

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FXX 1990-02-27

TECNOL LAZER(TM) SURGICAL MASK

Applicant Tecnol New Jersey Wound Care, Inc.

K number K896193

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FXX 1989-11-03

SURGICAL MASK/DENTAL MASK

Applicant Ashton Medical Products, Inc.

K number K895077

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FXX 1989-09-12

FACE PROTECTION PAK(TM)

Applicant Protech Products

K number K894905

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FXX 1989-09-12

VISOSHIELD(TM), SURGICAL EYE PROTECTOR

Applicant Polamedco, Inc.

K number K894516

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FXX 1989-07-14

ISOLATION MASKS

Applicant James River Corp.

K number K893939

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FXX 1989-06-23

MODIFIED STERILIZATION OF TUR APRONS

Applicant Brant-Wald Surgicals, Inc.

K number K893634

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FXX 1989-06-22

SURGIFRESH SUB-MICRON MASK NO. 901008-000

Applicant Texas Medical Products, Inc.

K number K893417

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FXX 1989-05-15

SAFE-T-FACE DISPOSABLE FACE SHIELD

Applicant Barry S. Smith Co.

K number K892451

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FXX 1989-04-18

CARERITE FACE MASK

Applicant Cost Rite Health Products, Inc.

K number K891141

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FXX 1989-04-12

SURGICAL CONE MASK

Applicant Dispomed, Inc.

K number K891056

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FXX 1989-04-12

SPLASH GUARD GOGGLE

Applicant Dispomed, Inc.

K number K891052

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FXX 1989-04-12

SURGICAL FACE MASK-EAR LOOP

Applicant Dispomed, Inc.

K number K891051

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FXX 1989-04-07

PRECEPT MICRO-GARD LASER MASK

Applicant Mars White Knight

K number K891409

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FXX 1989-03-14

ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK

Applicant 3M Company

K number K890771

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FXX 1989-02-14

FACELOCK FILTER MASK

Applicant Alpha Protech, Inc.

K number K890128

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FXX 1989-02-03

FACE MASK

Applicant Anjudd Intl.

K number K890016

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FXX 1989-01-10

OCUSHIELDS MASKS

Applicant Dioptics

K number K884877

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FXX 1988-12-15

OCCUSHIELDS

Applicant Dioptics

K number K884929

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FXX 1988-11-18

KBM DENTAL MASK

Applicant Kawamoto Bandage Material Co., Ltd.

K number K884392

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FXX 1988-11-17

MASKS, VARIOUS TYPES OF SURGICAL MASKS

Applicant Greene International Corp.

K number K883827

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FXX 1988-11-14

FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS

Applicant Select Sources, Inc.

K number K883705

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FXX 1988-10-25

I-SPOSE EYE SHIELD

Applicant Products For Medicine

K number K883658

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FXX 1988-10-03

CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS

Applicant Greene International Corp.

K number K883828

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FXX 1988-09-06

ZEPHYR

Applicant Racal Health & Safety, Inc.

K number K880534

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FXX 1988-08-10

C-MASK(FLAT)

Applicant Promedica Products, Inc.

K number K882883

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FXX 1988-08-10

C-MASK

Applicant Promedica Products, Inc.

K number K882882

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FXX 1988-07-08

PROTECTO-SHIELD

Applicant Syntech Mfg. Services

K number K881913

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FXX 1988-06-15

COVERALL SHIELD

Applicant Bfd, Inc.

K number K882028

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FXX 1988-06-15

COMBO-SHIELD

Applicant Bfd, Inc.

K number K882027

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FXX 1988-06-15

ADD-A-SHIELD

Applicant Bfd, Inc.

K number K882026

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FXX 1988-05-18

LABELING CHANGE TO SURGICAL FACE MASK

Applicant Louis M. Gerson Co., Inc.

K number K881910

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FXX 1988-05-09

ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK

Applicant 3M Company

K number K881618

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FXX 1988-04-08

ENDICOTT & BEAMAN SUPRA-TEC FACE MASK

Applicant Endicott & Beaman, Inc.

K number K881372

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FXX 1988-03-28

TECNOL LASER SURGICAL MASK

Applicant Tecnol New Jersey Wound Care, Inc.

K number K874894

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FXX 1988-03-11

TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD

Applicant Tecnol New Jersey Wound Care, Inc.

K number K880757

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FXX 1988-03-11

GUARDALL SHIELD

Applicant Anago, Inc.

K number K875008

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FXX 1988-03-04

ACCO(R) FACE MASK

Applicant Absorbent Cotton Co., Inc.

K number K880613

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FXX 1988-01-22

KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001

Applicant Welch Allyn, Inc.

K number K875194

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FXX 1988-01-22

DISPOSABLE SURGICAL FACE MASK

Applicant Irema USA , Ltd.

K number K875172

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FXX 1988-01-15

SAFETY SHIELD KIT

Applicant Ballard Medical Products

K number K873731

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FXX 1988-01-07

INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER

Applicant Ulti-Med Intl., Inc.

K number K874296

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FXX 1987-12-02

TECNOL FLUID SHIELD SURGICAL MASK

Applicant Tecnol New Jersey Wound Care, Inc.

K number K874608

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FXX 1987-11-09

ANTI-INFECTION SHIELD

Applicant Stackhouse Assoc.

K number K872935

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FXX 1987-11-02

TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE

Applicant Tecnol New Jersey Wound Care, Inc.

K number K873785

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FXX 1987-10-05

CARERITE FACE MASK

Applicant Cost Rite Health Products, Inc.

K number K873705

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FXX 1987-07-22

DENTAL FACE MASKS, POLYESTER

Applicant Carl Parker Associates, Inc.

K number K871558

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FXX 1987-02-24

WHITE PLUME SURGICAL GAUZE FACE MASK

Applicant China National Medicines & Health Prod. I/E Corp.

K number K870312

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FXX 1987-02-06

TECNOL CLASSIC CONE MASK

Applicant Tecnol New Jersey Wound Care, Inc.

K number K870056

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FXX 1985-04-30

OP-FACE MASK(MASQUE DE CHIRUGIE)

Applicant Roseburg SA

K number K851556

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FXX 1985-02-14

PERITONEAL DIALYSIS COIL CATHETER

Applicant Sil-Med Corp.

K number K850247

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FXX 1984-07-17

HIGH FILTRATION ISO-MASK

Applicant Tecnol New Jersey Wound Care, Inc.

K number K831148

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FXX 1983-08-12

TWO-PLY PAPER FACE FACE MASK

Applicant Abco Dealers, Inc.

K number K832281

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FXX 1983-07-26

SURGICAL FACE MASK-DISPOSABLE

Applicant Tecnol New Jersey Wound Care, Inc.

K number K832194

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FXX 1983-04-27

SURGICAL FACE MASK

Applicant Busse Hospital Disposables, Inc.

K number K830890

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FXX 1983-01-07

SPUNGUARD FACE MASK

Applicant Kimberly-Clark Corp.

K number K823078

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FXX 1982-09-17

MULTIPLE SURGICAL MASK

Applicant Surgilite Intl., Inc.

K number K822481

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FXX 1982-04-14

DISPOSABLE SURGICAL FACE MASK

Applicant Anago, Inc.

K number K820893

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FXX 1981-12-18

CONTURA DISPOS. SURG. FACE MASK

Applicant American Convertors Div., American Pharmaseal

K number K813078

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FXX 1981-12-03

FILTER FLOW MASK CAT. #350

Applicant Eldredge Mfg. Co.

K number K812997

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FXX 1981-12-03

FILTER FLOW MASK CAT. #300

Applicant Eldredge Mfg. Co.

K number K812996

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FXX 1981-12-03

SURGICAL MASK

Applicant South Mountain Medical

K number K812992

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FXX 1981-10-13

DISPOSABLE SURGICAL FACE MASKS

Applicant Irema USA , Ltd.

K number K812675

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FXX 1981-02-23

SURGIKOS FACE MASK

Applicant Surgikos, Inc.

K number K810316

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FXX 1980-11-12

SURGICAL FACE MASK

Applicant Louis M. Gerson Co., Inc.

K number K802373

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FXX 1980-06-04

SURGICAL MASK

Applicant American Threshold Industries, Inc.

K number K801036

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FXX 1979-11-05

CONPHAR FACE MASK-STERILE

Applicant Conphar, Inc.

K number K792110

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FXX 1978-06-22

MASK, SURGEONS

Applicant Abco Dealers, Inc.

K number K780607

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FXX 1978-05-26

MASK, ISOLATION

Applicant Abco Dealers, Inc.

K number K780609

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FXX 1978-02-13

MASK, SURGICAL

Applicant Convertors

K number K780169

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FXX 1977-10-27

DISP. SURGICAL FACE MASK

Applicant Precept, Inc.

K number K771409

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FXX 1977-04-29

MASK, SURGICAL, DISP

Applicant Acme Automatic Disposable

K number K770513

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FXX 1977-03-23

MASK, SURGICAL, FACE, DISPOSABLE

Applicant Precept, Inc.

K number K770463

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