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 5 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143287 | Fluidshield* Surgical Mask with Expanded Chamber | Halyard Health, Inc. | 2015-03-24 | Abbreviated | PDF ↗ |
| K142990 | Insta-Gard Surgical and Procedure Face Mask | Cardinal Health200, LLC | 2015-03-04 | Traditional | PDF ↗ |
| K140155 | SECURE-GARD SURGICAL AND PROCEDURE FACE MASK | Cardinal Health200, LLC | 2014-06-20 | Traditional | PDF ↗ |
| K131879 | KC 300 SURGICAL MASK | Kimberly-Clark Corp. | 2013-12-20 | Traditional | PDF ↗ |
| K123787 | GREENCROSS SURGICAL MASK | Jingzhou Haixin Green Cross Medical Products Co.,L | 2013-07-17 | Traditional | PDF ↗ |
| K123115 | ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P | Acme Filter Mask, Inc. | 2013-05-20 | Traditional | PDF ↗ |
| K122717 | FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK | Tiger Medical Products, Ltd. | 2012-12-21 | Abbreviated | PDF ↗ |
| K111402 | KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL | Kimberly-Clark | 2011-10-20 | Abbreviated | PDF ↗ |
| K111343 | CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS | Crosstex International, Inc. | 2011-10-06 | Traditional | PDF ↗ |
| K111559 | SURGICAL MASKS | Shanghai Neo-Medical Import & Export Co., Ltd. | 2011-09-16 | Traditional | PDF ↗ |
| K110027 | SURGICAL FACE MASK; SURGICAL FACE MASK | Angeline Group , Ltd. | 2011-08-05 | Traditional | PDF ↗ |
| K110455 | KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS | Kimberly-Clark Corp. | 2011-04-29 | Abbreviated | PDF ↗ |
| K102713 | TIGER FLAT SURGICAL MASK | Tiger Medical Products, Ltd. | 2011-01-25 | Abbreviated | PDF ↗ |
| K103303 | CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE | Crosstex International, Inc. | 2010-12-23 | Traditional | PDF ↗ |
| K093901 | SURGICAL FACE MASK | Epard Protective Products, Ltd. | 2010-09-10 | Traditional | PDF ↗ |
| K100846 | IMC SURGICAL FACE MASK | International Medsurg Connection | 2010-08-16 | Traditional | PDF ↗ |
| K101000 | WELLMIEN SURGICAL MASK | Wellmien (Suzhou) Import & Export Trading Co., Ltd. | 2010-08-09 | Abbreviated | PDF ↗ |
| K093179 | MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) | H&H Research Company | 2010-07-14 | Abbreviated | PDF ↗ |
| K100800 | TIDI FACEMASK | Tidi Products,Llc | 2010-06-14 | Traditional | PDF ↗ |
| K092580 | TIDI FACEMASK | Tidi Products,Llc | 2010-02-23 | Traditional | PDF ↗ |
| K092012 | PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 | Primed Medical Products, Inc. | 2009-09-25 | Special | PDF ↗ |
| K082258 | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR | Crosstex International | 2008-10-16 | Traditional | PDF ↗ |
| K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | Primed Medical Products, Inc. | 2008-08-11 | Special | PDF ↗ |
| K070407 | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE | Dukal Corp. | 2007-03-26 | Traditional | PDF ↗ |
| K063043 | SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP | Modern Healthcare Corp. | 2007-03-21 | Traditional | PDF ↗ |
| K061864 | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 | Dukal Corp. | 2006-09-15 | Traditional | PDF ↗ |
| K061716 | PRESTIGE AMERITECH FACE MASK | Prestige Ameritech | 2006-08-14 | Abbreviated | PDF ↗ |
| K060776 | SURGICAL FACE MASK | Hong YA Non-Woven Products Co., Ltd. | 2006-05-25 | Traditional | PDF ↗ |
| K050689 | SURGICAL FACE MASK | China Surgical Dressings Center Co., Ltd. | 2005-10-26 | Traditional | PDF ↗ |
| K051291 | NON-STERILE SURGICAL MASK | A.R. Medicom, Inc. | 2005-09-20 | Traditional | PDF ↗ |
| K043199 | SURGICAL FACE MASK | Hong YA Non-Woven Products Co., Ltd. | 2005-02-16 | Traditional | PDF ↗ |
| K042654 | PROTECTION PLUS EARLOOP PROCEDURE MASK | Safety-Med Products, Inc. | 2004-12-17 | Traditional | PDF ↗ |
| K041047 | ULTRADENT CARBON MASK - UPI #342 | Medspring Group, Incorporated | 2004-12-01 | Abbreviated | PDF ↗ |
| K040333 | VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS | Valumax Intl., Inc. | 2004-06-07 | Traditional | PDF ↗ |
| K022256 | SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN | Tucker & Associates | 2004-04-26 | Traditional | PDF ↗ |
| K034015 | EARLOOP PROCEDURE MASK | Medipack Medical Packaging Mfg. Co. | 2004-02-20 | Traditional | PDF ↗ |
| K030239 | MEGATECH SCIENTIFIC FACE MASK | Megatech Scientific Pte, Ltd. | 2003-07-24 | Traditional | PDF ↗ |
| K031353 | SOLUTION FACE MASKS | A Plus International, Inc. | 2003-06-19 | Traditional | PDF ↗ |
| K023755 | WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD | Winner Industries (Shenzhen) Co., Ltd. | 2003-06-10 | Traditional | PDF ↗ |
| K021546 | DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR | Creative Contract (M) Sdn Bhd | 2003-03-05 | Traditional | PDF ↗ |
| K021533 | DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE) | Creative Contract (M) Sdn Bhd | 2003-03-05 | Traditional | PDF ↗ |
| K021539 | DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS | Creative Contract (M) Sdn Bhd | 2003-03-05 | Traditional | PDF ↗ |
| K021076 | PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM | Primeline Medical Products, Inc. | 2002-04-16 | Special | PDF ↗ |
| K012602 | CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX | Crosstex Intl. | 2002-01-22 | Traditional | PDF ↗ |
| K011789 | PROCEDURE MASKS: PM4-301 AND PM4-304 | Primeline Medical Products, Inc. | 2001-06-22 | Special | PDF ↗ |
| K001892 | WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) | White Knight Healthcare, Inc. | 2001-04-03 | Traditional | PDF ↗ |
| K001893 | WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) | White Knight Healthcare, Inc. | 2001-04-02 | Traditional | PDF ↗ |
| K001997 | WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) | White Knight Healthcare, Inc. | 2001-04-02 | Traditional | PDF ↗ |
| K001951 | PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 | Primeline Medical Products, Inc. | 2000-09-08 | Traditional | PDF ↗ |
| K992604 | HENRY SCHEIN SURGICAL MASK | Mitsui Textile Corp. | 2000-01-28 | Traditional | PDF ↗ |
| K991559 | MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD | Medline Industries, Inc. | 1999-08-23 | Traditional | PDF ↗ |
| K990719 | EARLOOP FACE MASK | Shuenn Bao Shing Corp. | 1999-07-12 | Traditional | PDF ↗ |
| K984389 | TOP WHOLESOME FACE MASK | Top Wholesome Enterprise Co., Ltd. | 1999-04-09 | Traditional | PDF ↗ |
| K972849 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | Cypress Medical Products, Ltd. | 1998-05-28 | Traditional | PDF ↗ |
| K972883 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | Cypress Medical Products, Ltd. | 1998-02-26 | Traditional | PDF ↗ |
| K970835 | FACE MASK, SURGICAL MASK, NON-STERILE | Tucker & Associates | 1997-09-03 | Traditional | PDF ↗ |
| K971744 | FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) | Berkley Medical Resources, Inc. | 1997-07-28 | Traditional | PDF ↗ |
| K971130 | DEFEND FLUID RESISTANT PLEATED MASK | Carl Parker Associates, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K964114 | DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS | Depuy, Inc. | 1997-05-06 | Traditional | PDF ↗ |
| K970440 | EKONIC DENTAL/MEDICAL MASK (MD 610) | Ekonic Company, Ltd. | 1997-03-27 | Traditional | PDF ↗ |
| K965107 | MEDLINE ADMISSION KITS | Medline Industries, Inc. | 1997-03-11 | Traditional | PDF ↗ |
| K965043 | 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE | Minnesota Mining and Mfg. Co. | 1997-03-10 | Traditional | PDF ↗ |
| K964168 | PROCEDURE SPECIFIC KITS | Sage Products, Inc. | 1997-03-03 | Traditional | PDF ↗ |
| K963568 | MASK SURGICAL | The Innovative Approach, Corp. | 1997-02-25 | Traditional | PDF ↗ |
| K964358 | AMSEAL SURGICAL FACE MASK | American Seal Co. | 1997-02-14 | Traditional | PDF ↗ |
| K964722 | DELTA N95 RESPIRATOR | Racal Filter Technologies, Inc. | 1997-02-07 | Traditional | PDF ↗ |
| K964723 | RACAL N95 RESIRATOR | Racal Filter Technologies, Inc. | 1997-02-07 | Traditional | PDF ↗ |
| K962654 | COMPLEAT SURGICAL MASK | Carl Parker Associates, Inc. | 1997-01-27 | Traditional | PDF ↗ |
| K962443 | N95 FILTERING FACEPIECE | Survivair, Inc. | 1997-01-03 | Traditional | PDF ↗ |
| K962286 | 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD | Berkley Medical Resources, Inc. | 1996-10-07 | Traditional | PDF ↗ |
| K961217 | BODILY FLUID DISPOSAL KIT | Transidyne General Corp. | 1996-07-25 | Traditional | PDF ↗ |
| K960048 | EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS | Safetec of America, Inc. | 1996-07-12 | Traditional | PDF ↗ |
| K961402 | STS SHIELD WITH MASK | Innovative Outsourcing Solutions | 1996-07-12 | Traditional | PDF ↗ |
| K955382 | 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 | 3M Company | 1996-05-01 | Traditional | PDF ↗ |
| K955556 | FLUID RESISTANT MASK | American Threshold Healthcare | 1996-04-25 | Traditional | PDF ↗ |
| K955557 | FLUID REISISTANT EYESHIELD MASK | American Threshold Healthcare | 1996-04-25 | Traditional | PDF ↗ |
| K955513 | SURGICAL MASK (NON-STERILE) | United Medical Ent., Inc. | 1996-04-22 | Traditional | PDF ↗ |
| K953754 | GLOBAL HEALTHCARE FACE MASK | Global Healthcare, Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K952961 | BODY FLUID BARRIER KIT | Lhb Industries, Inc. | 1996-01-23 | Traditional | PDF ↗ |
| K953102 | BLOODBORNE PATHOGEN KIT | Certified Safety Mfg., Inc. | 1995-12-11 | Traditional | PDF ↗ |
| K951913 | OVAL SURGICAL FACE MASK | Oval Industries, Ltd. | 1995-10-12 | Traditional | PDF ↗ |
| K952962 | EZ-PERSONAL PROTECTION KIT | Safetec of America, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K950554 | NORTH BLOODBORNE PATHOGEN RESPONSE KIT | North Safety Products | 1995-06-28 | Traditional | PDF ↗ |
| K946001 | EMERGENCY RESPONSE SAFETY KIT | Ani Safety, Inc. | 1995-06-09 | Traditional | PDF ↗ |
| K933683 | PENTAX FACE MASK | Pentax Precision Instrument Corp. | 1995-06-02 | Traditional | PDF ↗ |
| K946343 | INTEC EXTENDED EYE SHIELD WITH MASK | Intec Industries, Inc. | 1995-03-22 | Traditional | PDF ↗ |
| K944880 | BODILY FLUID DISPOSAL KIT | Clinical Resources, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K944545 | BODY FLUIDS BARRIER KIT | Ani Safety, Inc. | 1994-11-02 | Traditional | PDF ↗ |
| K940720 | BUSSE ISOLATION AND PROCEDURAL MASKS | Busse Hospital Disposables, Inc. | 1994-11-02 | Traditional | PDF ↗ |
| K942473 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592 | Protectaide, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K942472 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123 | Protectaide, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K942470 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315 | Protectaide, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K942476 | PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069 | Protectaide, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K942474 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 | Protectaide, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K942475 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351 | Protectaide, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K942471 | PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777 | Protectaide, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K933748 | SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD | Bam Corp., Ltd. | 1994-06-17 | Traditional | PDF ↗ |
| K940707 | 3M SURGICAL MASK WITH FACE SHEILD | 3M Company | 1994-05-23 | Traditional | PDF ↗ |
| K932834 | TECNOL PCM 2000 | Tecnol Medical Products, Inc. | 1994-05-03 | Traditional | PDF ↗ |
| K931580 | DISPOSABLE SURGICAL MASK (MODIFIED) | Bam Corp., Ltd. | 1994-05-02 | Traditional | PDF ↗ |
Product code FXX · Class II · General, Plastic Surgery. Data: openFDA.