FDA Product Code
FDA Product Code FXX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 607 records · page 6 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K932132 | EYSOTEK | Isotech Corp. | 1994-04-29 | Traditional | PDF ↗ |
| K932133 | EYSOTEK | Isotech Corp. | 1994-04-29 | Traditional | PDF ↗ |
| K932137 | FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR | Tecnol Medical Products, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K934974 | FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD | Mid America Medical, Inc. | 1994-04-13 | Traditional | PDF ↗ |
| K934969 | DUALGARD FACE SHIELD | White Knight Healthcare | 1994-03-28 | Traditional | PDF ↗ |
| K934194 | BARRIER LASER PLUS FACE MASK | Johnson & Johnson Medical, Inc. | 1994-03-28 | Traditional | PDF ↗ |
| K920108 | BARRIER EXTRA PROTECTION PLUS FACE MASK | Johnson & Johnson Medical, Inc. | 1994-02-10 | Traditional | PDF ↗ |
| K925185 | ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS | Louis M. Gerson Co., Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K930067 | BUFFALO FILTER SURGICAL MASK | Buffalo Filter Co., Inc. | 1993-11-30 | Traditional | PDF ↗ |
| K915817 | TECNOL FLUIDSHIELD INFECTION CONTROL MASK | Tecnol Medical Products, Inc. | 1993-01-27 | Traditional | PDF ↗ |
| K920162 | TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK | Tecnol Medical Products, Inc. | 1993-01-27 | Traditional | PDF ↗ |
| K922507 | GERSON ISOLAIR APR PARTICULATE SURGICAL MASK | Louis M. Gerson Co., Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K922716 | SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509 | Splash Shield, Inc. | 1992-10-23 | Traditional | PDF ↗ |
| K920203 | TECNOL INFECTION CONTROL MASK | Tecnol Medical Products, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K920846 | CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER | Trinity Laboratories, Inc. | 1992-09-01 | Traditional | PDF ↗ |
| K920682 | PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001 | Phoenix Steri-Tech, Inc. | 1992-04-28 | Traditional | PDF ↗ |
| K914832 | SURGICAL APPAREL | W. L. Gore & Associates, Inc. | 1992-02-14 | Traditional | PDF ↗ |
| K914412 | MASK, SURGICAL, DISPOSABLE | Industries For the Blind | 1991-12-19 | Traditional | PDF ↗ |
| K913558 | RELIABLE CONE STYLE FACE MASK | Anago, Inc. | 1991-11-07 | Traditional | PDF ↗ |
| K911334 | MASK, SURGICAL APPAREL | Thai Hospital Products Co., Ltd. | 1991-08-29 | Traditional | PDF ↗ |
| K913043 | MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS | Tecnol New Jersey Wound Care, Inc. | 1991-08-23 | Traditional | PDF ↗ |
| K911891 | FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK | Tecnol New Jersey Wound Care, Inc. | 1991-07-12 | Traditional | PDF ↗ |
| K911907 | FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS | Tecnol New Jersey Wound Care, Inc. | 1991-07-08 | Traditional | PDF ↗ |
| K910557 | BARRIER* EXTRA PROTECTION PLUS FACE MASK | Johnson & Johnson Medical, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K910110 | TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK | 3M Company | 1991-03-20 | Traditional | PDF ↗ |
| K905865 | ANTI-FOR SURGICAL FACE MASK | Anago, Inc. | 1991-03-06 | Traditional | PDF ↗ |
| K910182 | 3M BRAND EAR LOOP FACE MASK, 2000F | 3M Company | 1991-03-04 | Traditional | PDF ↗ |
| K905749 | SURGICAL FACE MASK | Anago, Inc. | 1991-03-04 | Traditional | PDF ↗ |
| K905209 | SURGICAL MASK | Lancaster County Blind Assoc. | 1991-02-21 | Traditional | PDF ↗ |
| K903486 | MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493 | Pennsylvania Association For the Blind | 1990-10-23 | Traditional | PDF ↗ |
| K902546 | THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK | Anago, Inc. | 1990-09-05 | Traditional | PDF ↗ |
| K902547 | THE PROTECTOR II, LASER SURGICAL MASK | Anago, Inc. | 1990-09-05 | Traditional | PDF ↗ |
| K900665 | DRESSING CHANGE KIT | Healthdyne Cardiovascular, Inc. | 1990-05-14 | Traditional | PDF ↗ |
| K900088 | MASKS SURGICAL DENTAL | Kab Gloves Unltd. | 1990-03-08 | Traditional | PDF ↗ |
| K896193 | TECNOL LAZER(TM) SURGICAL MASK | Tecnol New Jersey Wound Care, Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K895077 | SURGICAL MASK/DENTAL MASK | Ashton Medical Products, Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K894516 | VISOSHIELD(TM), SURGICAL EYE PROTECTOR | Polamedco, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K894905 | FACE PROTECTION PAK(TM) | Protech Products | 1989-09-12 | Traditional | PDF ↗ |
| K893939 | ISOLATION MASKS | James River Corp. | 1989-07-14 | Traditional | PDF ↗ |
| K893634 | MODIFIED STERILIZATION OF TUR APRONS | Brant-Wald Surgicals, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893417 | SURGIFRESH SUB-MICRON MASK NO. 901008-000 | Texas Medical Products, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K892451 | SAFE-T-FACE DISPOSABLE FACE SHIELD | Barry S. Smith Co. | 1989-05-15 | Traditional | PDF ↗ |
| K891141 | CARERITE FACE MASK | Cost Rite Health Products, Inc. | 1989-04-18 | Traditional | PDF ↗ |
| K891052 | SPLASH GUARD GOGGLE | Dispomed, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K891056 | SURGICAL CONE MASK | Dispomed, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K891051 | SURGICAL FACE MASK-EAR LOOP | Dispomed, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K891409 | PRECEPT MICRO-GARD LASER MASK | Mars White Knight | 1989-04-07 | Traditional | PDF ↗ |
| K890771 | ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK | 3M Company | 1989-03-14 | Traditional | PDF ↗ |
| K890128 | FACELOCK FILTER MASK | Alpha Protech, Inc. | 1989-02-14 | Traditional | PDF ↗ |
| K890016 | FACE MASK | Anjudd Intl. | 1989-02-03 | Traditional | PDF ↗ |
| K884877 | OCUSHIELDS MASKS | Dioptics | 1989-01-10 | Traditional | PDF ↗ |
| K884929 | OCCUSHIELDS | Dioptics | 1988-12-15 | Traditional | PDF ↗ |
| K884392 | KBM DENTAL MASK | Kawamoto Bandage Material Co., Ltd. | 1988-11-18 | Traditional | PDF ↗ |
| K883827 | MASKS, VARIOUS TYPES OF SURGICAL MASKS | Greene International Corp. | 1988-11-17 | Traditional | PDF ↗ |
| K883705 | FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS | Select Sources, Inc. | 1988-11-14 | Traditional | PDF ↗ |
| K883658 | I-SPOSE EYE SHIELD | Products For Medicine | 1988-10-25 | Traditional | PDF ↗ |
| K883828 | CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS | Greene International Corp. | 1988-10-03 | Traditional | PDF ↗ |
| K880534 | ZEPHYR | Racal Health & Safety, Inc. | 1988-09-06 | Traditional | PDF ↗ |
| K882882 | C-MASK | Promedica Products, Inc. | 1988-08-10 | Traditional | PDF ↗ |
| K882883 | C-MASK(FLAT) | Promedica Products, Inc. | 1988-08-10 | Traditional | PDF ↗ |
| K881913 | PROTECTO-SHIELD | Syntech Mfg. Services | 1988-07-08 | Traditional | PDF ↗ |
| K882028 | COVERALL SHIELD | Bfd, Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K882027 | COMBO-SHIELD | Bfd, Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K882026 | ADD-A-SHIELD | Bfd, Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K881910 | LABELING CHANGE TO SURGICAL FACE MASK | Louis M. Gerson Co., Inc. | 1988-05-18 | Traditional | PDF ↗ |
| K881618 | ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK | 3M Company | 1988-05-09 | Traditional | PDF ↗ |
| K881372 | ENDICOTT & BEAMAN SUPRA-TEC FACE MASK | Endicott & Beaman, Inc. | 1988-04-08 | Traditional | PDF ↗ |
| K874894 | TECNOL LASER SURGICAL MASK | Tecnol New Jersey Wound Care, Inc. | 1988-03-28 | Traditional | PDF ↗ |
| K880757 | TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD | Tecnol New Jersey Wound Care, Inc. | 1988-03-11 | Traditional | PDF ↗ |
| K875008 | GUARDALL SHIELD | Anago, Inc. | 1988-03-11 | Traditional | PDF ↗ |
| K880613 | ACCO(R) FACE MASK | Absorbent Cotton Co., Inc. | 1988-03-04 | Traditional | PDF ↗ |
| K875194 | KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001 | Welch Allyn, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K875172 | DISPOSABLE SURGICAL FACE MASK | Irema USA , Ltd. | 1988-01-22 | Traditional | PDF ↗ |
| K873731 | SAFETY SHIELD KIT | Ballard Medical Products | 1988-01-15 | Traditional | PDF ↗ |
| K874296 | INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER | Ulti-Med Intl., Inc. | 1988-01-07 | Traditional | PDF ↗ |
| K874608 | TECNOL FLUID SHIELD SURGICAL MASK | Tecnol New Jersey Wound Care, Inc. | 1987-12-02 | Traditional | PDF ↗ |
| K872935 | ANTI-INFECTION SHIELD | Stackhouse Assoc. | 1987-11-09 | Traditional | PDF ↗ |
| K873785 | TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE | Tecnol New Jersey Wound Care, Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K873705 | CARERITE FACE MASK | Cost Rite Health Products, Inc. | 1987-10-05 | Traditional | PDF ↗ |
| K871558 | DENTAL FACE MASKS, POLYESTER | Carl Parker Associates, Inc. | 1987-07-22 | Traditional | PDF ↗ |
| K870312 | WHITE PLUME SURGICAL GAUZE FACE MASK | China National Medicines & Health Prod. I/E Corp. | 1987-02-24 | Traditional | PDF ↗ |
| K870056 | TECNOL CLASSIC CONE MASK | Tecnol New Jersey Wound Care, Inc. | 1987-02-06 | Traditional | PDF ↗ |
| K851556 | OP-FACE MASK(MASQUE DE CHIRUGIE) | Roseburg SA | 1985-04-30 | Traditional | PDF ↗ |
| K850247 | PERITONEAL DIALYSIS COIL CATHETER | Sil-Med Corp. | 1985-02-14 | Traditional | PDF ↗ |
| K831148 | HIGH FILTRATION ISO-MASK | Tecnol New Jersey Wound Care, Inc. | 1984-07-17 | Traditional | PDF ↗ |
| K832281 | TWO-PLY PAPER FACE FACE MASK | Abco Dealers, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K832194 | SURGICAL FACE MASK-DISPOSABLE | Tecnol New Jersey Wound Care, Inc. | 1983-07-26 | Traditional | PDF ↗ |
| K830890 | SURGICAL FACE MASK | Busse Hospital Disposables, Inc. | 1983-04-27 | Traditional | PDF ↗ |
| K823078 | SPUNGUARD FACE MASK | Kimberly-Clark Corp. | 1983-01-07 | Traditional | PDF ↗ |
| K822481 | MULTIPLE SURGICAL MASK | Surgilite Intl., Inc. | 1982-09-17 | Traditional | PDF ↗ |
| K820893 | DISPOSABLE SURGICAL FACE MASK | Anago, Inc. | 1982-04-14 | Traditional | PDF ↗ |
| K813078 | CONTURA DISPOS. SURG. FACE MASK | American Convertors Div., American Pharmaseal | 1981-12-18 | Traditional | PDF ↗ |
| K812996 | FILTER FLOW MASK CAT. #300 | Eldredge Mfg. Co. | 1981-12-03 | Traditional | PDF ↗ |
| K812992 | SURGICAL MASK | South Mountain Medical | 1981-12-03 | Traditional | PDF ↗ |
| K812997 | FILTER FLOW MASK CAT. #350 | Eldredge Mfg. Co. | 1981-12-03 | Traditional | PDF ↗ |
| K812675 | DISPOSABLE SURGICAL FACE MASKS | Irema USA , Ltd. | 1981-10-13 | Traditional | PDF ↗ |
| K810316 | SURGIKOS FACE MASK | Surgikos, Inc. | 1981-02-23 | Traditional | PDF ↗ |
| K802373 | SURGICAL FACE MASK | Louis M. Gerson Co., Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K801036 | SURGICAL MASK | American Threshold Industries, Inc. | 1980-06-04 | Traditional | PDF ↗ |
| K792110 | CONPHAR FACE MASK-STERILE | Conphar, Inc. | 1979-11-05 | Traditional | PDF ↗ |
Product code FXX · Class II · General, Plastic Surgery. Data: openFDA.