BEUDAMED
    Product Code: FXX FDA class 2 21 CFR 878.4040

    Mask, Surgical

    General, Plastic Surgery

    A surgical mask is a loose-fitting, disposable face covering worn by surgical personnel to reduce the transmission of microorganisms from the wearer to the surgical field, protecting the sterile environment and the patient. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FXX, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    599
    FEI Numbers
    329
    Registration Numbers
    329
    Unique Applicants
    484
    Years Active
    49

    Basic Information

    Product Code
    FXX
    Device Class
    FDA class 2
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 599 510(k) clearances via K numbers.

    K Number Device Name
    K250082 Procedure mask/Surgical mask/Face mask
    K243010 Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce
    K242502 Aurelia Surgical Mask ASTM Level-3 (2130)
    K240916 Surgical Face Mask (Tie on/ Ear loops)
    K240286 PRIMED Surgical Masks and PRIMED Procedure Masks
    K233723 Medical surgical mask
    K232824 FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
    K232777 FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
    K232807 Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
    K232812 Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)
    K232806 HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)
    K232968 Grande Medical Masks, Model SF-600
    K232820 HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
    K240258 Disposable Medical Face Mask (M643BE)
    K232112 R&G Surgical Mask
    K231719 Medical Surgical Mask
    K232894 HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)
    K232797 Hygenix
    K231005 Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
    K231155 Biodegradable Medical surgical mask
    K232359 Surgical face mask
    K230380 Surgical Face Masks, Model: EFMDS-L50Pn BLU
    K231618 3 Layer Surgical Mask (134252531)
    K230395 Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
    K230569 Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
    K230617 Surgical Face Mask (L 175*95mm)
    K222545 Disposable Medical Mask
    K223823 Disposable Surgical Face Mask
    K223236 Medline Surgical Face Mask and Medline Procedural Face Mask
    K221352 Surgical Face Mask
    K221209 PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
    K230383 Savvy Surgical Mask - Level 3
    K223232 Procedure mask/Surgical mask/Face mask
    K230093 Disposable 4 Layers Surgical Face Mask
    K223686 Medical Protective Masks
    K221682 Ideal Med Pro 3-Ply Disposable Face Mask
    K203380 Disposable Surgical Face Mask
    K222483 Surgical Face Mask
    K222809 Medical Disposable Face Masks
    K213601 Surgical Mask
    K220520 PM Excellence SEQUR 100 Surgical Face Mask
    K222651 Surgical Face Mask
    K223045 3-Ply Disposable Medical Mask
    K223055 Disposable Medical Face Mask
    K223068 Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
    K223003 Banded Face Mask
    K220302 Disposable surgical face mask
    K203528 KNH Surgical Face Mask
    K222749 High Fluid-Resistant Surgical and Procedure Mask
    K222529 Surgical Face Mask
    K222551 Humask Pro Vision, Humask Pro Vision 3000
    K222697 Disposable Medical Face Mask (DF3-001)
    K223270 POSE™ Health Care Surgical Mask
    K212649 Disposable Surgical Face Mask
    K222335 Surgical Mask
    K222266 Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
    K222204 Medical Surgical Mask
    K221976 Surgical Face Mask (Non-sterile)
    K221534 Surgical Face Masks (Ear Loops And Tie-On)
    K212926 AllureTM Surgical Mask
    K214035 LAITEST Medical Face Mask
    K220944 PointCore Surgical Mask
    K222426 Perfetta Moderate Medical Face Mask
    K221957 Savewo ClassicMASK
    K221038 Disposable Medical Masks
    K220067 Medical Surgery Mask, Model:2626-7
    K211771 The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask
    K203078 CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
    K221838 Surgical Face Mask (HNFM0103)
    K212273 Cross Protection ResQ300 Plus Surgical Face Mask
    K220876 AOK 95A Medical Mask (20200049)
    K221409 Paneffort 3-ply Surgical and Procedural Masks
    K221196 Disposable Medical Face Mask (ear loop)
    K220777 Surgical face mask
    K221173 Surgical Mask (Model: 0868F, 0866F)
    K220378 Sparta 3-Ply Surgical Disposable Face Mask
    K221273 Medical Face Mask (M001)
    K221272 Medical Face Mask
    K220670 Magnum
    K220377 Procedure Mask
    K220550 Disposable Surgical Face Mask (M663BE, M663BT)
    K221222 Surgical Face Mask (HNFM0304)
    K220597 Disposable Surgical Face Mask (FM-34EE,FM-44EE)
    K220191 Disposable Face Mask
    K220532 Disposable surgical mask
    K221134 Procedure Mask with Ear Loops and Surgical Mask with Ties
    K220824 Medical Surgical Mask (Planar type)
    K220194 Procedure mask/Surgical mask/Face mask
    K220749 Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
    K213001 Procedure Mask, Surgical Mask
    K220487 Disposable Medical Face Mask
    K220512 Disposable Surgical Face Mask (M01, M02)
    K212203 Dong Hai Xiang Surgical Mask
    K210860 Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
    K214085 Disposable Medical Mask
    K213450 Medical surgical mask (Black mask, Level 1 and Level 3)
    K213736 Medical Face Mask
    K210422 INTAI Surgical Mask (non-sterile)
    K220637 3 Ply Medical Grade Single Use Procedural Disposable Face Mask
    K220187 Medical Surgical Mask (Model: JM92, JM92B)
    K202903 Surgical Face Mask
    K212726 Disposable Medical Surgical Mask
    K213894 DWFritz ASM2000
    K212330 Yadu Medical Face Mask (Level 1)
    K213806 Disposable Medical Face Mask
    K214087 Medical Face Mask
    K213358 Surgical Mask
    K203376 ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G
    K214094 ROKI Surgical Mask
    K213724 Medical Surgical Mask
    K212863 Surgical Face Mask
    K212366 Heartland Health Surgical Mask
    K213617 Surgical Face Mask
    K212120 Surgical Masks
    K212610 Surgical Face Mask
    K210101 American-Made Surgical Mask
    K213347 ADI Medical Surgical Face Mask
    K213970 D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
    K212111 Myflon Surgical Mask Level 3
    K203161 Surgical Face Mask
    K212826 Disposable Medical Mask
    K210679 Medical Face Mask
    K212994 Medical Face Mask
    K213920 Kangbeier Surgical Mask (Model: KBR-1001)
    K211833 Disposable Medical Face Mask
    K212997 Surgical Mask
    K212913 Surgical Face Mask
    K211260 Sheng Jing Tang Surgical Mask
    K212375 Disposable Medical Surgical Mask
    K212299 Medical Surgical Mask
    K213136 CPL Surgical Face Mask
    K202255 Skypro, SP02 Mask (3)
    K210147 Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield
    K211750 Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
    K212059 Surgical Face Mask
    K210102 Topwide Surgical Face Mask
    K211378 LM Surgical Mask Level 3, LM Surgical Mask Level 2,
    K212944 Disposable Surgical Mask
    K212398 Surgical Face Mask (Non-sterile)
    K212574 Surgical Face Mask
    K210744 Surgical Mask
    K202794 Surgical face mask: F-Y1-A
    K212867 Medical Surgical Mask
    K211487 MAF Guard
    K212302 BAYLAB 3-Ply Surgical Mask (BEACON I)
    K212235 Surgical Face Mask
    K211772 PMW01 Procedure Mask Level 1
    K212807 Surgical Masks
    K212740 Puravita Medical Fold Flat Surgical Mask
    K211773 Single-use Surgical Mask
    K211696 Disposable Surgical Face Mask
    K202842 Medical surgical mask
    K211295 Surgical Mask (sterile)
    K211956 039 Surgical Face Mask
    K213406 Savvy Mask - Level 3 Surgical Face Mask
    K212046 Impertech Surgical Face Mask
    K210042 Disposable Surgical Mask
    K212344 Surgical Mask
    K212575 Surgical Face Mask
    K212109 Spin Care Disposable Protective Mask Level 3
    K212264 Surgical Face mask
    K212526 Surgical Face Mask
    K211165 Medical Face Masks, Model Name:MY020003
    K212460 Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
    K202676 Disposable Medical Face Mask
    K212471 Medical Face Mask
    K210222 Disposable Medical Mask
    K212293 Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
    K212368 Surgical Face Mask
    K210348 Disposable Medical Surgical Mask
    K203565 Surgical 3D Mask
    K212205 Medical Protective Masks
    K210845 Disposable Surgical Mask (Model: YYKZ-01)
    K210813 Medical Surgical Mask
    K210622 Single-Use Medical Face Mask
    K211899 Surgical Face Mask
    K211425 Private Stock Labs Surgical Face Mask
    K210513 UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2
    K211794 Disposable surgical mask
    K210878 Surgical Face Mask (Model: CM2006, CM2008, A88)
    K210908 Surgical Mask
    K211827 Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
    K211097 Banyan USA Surgical Mask Level 3
    K210772 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)
    K211751 WELLTRUST WT-III Mask with Flat Earloop
    K203418 Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
    K203112 Disposable Medical Mask
    K210184 Wilson Tech Disposable Medical Face Mask
    K203455 Disposable Medical Mask
    K211296 Surgical face mask
    K212451 Surgical Mask
    K211832 Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
    K211762 Altor Safety 4-Ply Surgical Mask (Model:62232)
    K211536 Welspun Health Surgical Mask
    K211255 Surgical Mask
    K202746 Surgical mask
    K211451 Disposable Surgical Mask (non sterile)
    K202745 Disposable medical face mask
    K211576 WYZ Surgical Mask
    K211462 Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask
    K211066 Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
    K210698 ECOMA Level 2 Disposable Surgical Mask with Ear Loops
    K210256 CiRx (R) Surgical Mask
    K212097 Disposable medical surgical mask
    K211631 Surgical Face Mask
    K211454 Surgical mask
    K211552 Surgical mask
    K211353 Medical Face Mask
    K203152 Disposable Face Mask
    K210643 Disposable Surgical Face Mask
    K211897 Surgical Face Mask
    K203174 Disposable Medical Mask
    K210870 MEO Med Disposable Medical Face Mask
    K211861 TAIJI Professional Series Level 3 Surgical Face Mask
    K211497 Surgical Mask
    K210856 Purism Disposable Surgical Mask
    K210409 Disposable Surgical Face Mask
    K211984 MASC Surgical Mask
    K211363 Medical Face Mask
    K211249 Altor Safety 3-Ply Surgical Mask (Model:62222)
    K210391 Single-use medical face mask
    K210970 Single-Use Surgical Mask Model FE2311B
    K203534 Surgical face mask (Model: Flat Ear Loop/CN102)
    K210761 Velguard Surgical Face Mask
    K211042 Disposable Procedural Ear-loop Face Mask
    K201844 Surgical Face Mask, Surgical Mask
    K210244 Disposable Medical Face Mask
    K210380 Medical surgical mask
    K210267 Disposable Surgical Mask
    K210524 Surgical Mask
    K203591 Single-use Medical Face Mask
    K202954 Disposable Surgical Mask
    K210445 Nordiwell Surprotect Face Mask
    K210840 Disposable Surgical Mask
    K203200 Disposable Medical Surgical Face Mask
    K211520 Amerishield Surgical Mask
    K210518 Surgical Face Mask
    K203732 Surgical Face Mask
    K202714 Medical Face Mask
    K210767 Surgical Masks, Model:FE-1
    K210015 Surgical Face Mask
    K203756 Disposable Surgical Mask
    K211062 Medical Face Mask
    K202126 Disposable Surgical Mask
    K210641 Disposable Medical Mask
    K210433 Surgical Face Mask (Ear loops and Tie-on)
    K210372 Disposable Surgical Mask
    K202580 Disposable Surgical Mask
    K203704 Surgical face mask
    K203388 Disposable medical mask
    K202128 Allmed Surgical Face Masks (Ear loops)
    K211440 ASM-301 Level 3 Surgical Mask
    K210429 Disposable Surgical Face Mask
    K210150 Disposable Medical mask
    K203190 Surgical Face Mask
    K211275 AirMax Procedure Mask
    K202899 Procedure Mask, Surgical Mask
    K211105 Ear-Friendly Mask
    K210302 Disposable Medical mask
    K210815 Disposable Face Mask
    K202697 United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask
    K210218 SURGICAL MASK, Model Name:C015
    K210705 Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3
    K202598 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3
    K210304 Surgical Mask
    K202457 M1 Surgical Face Mask
    K210020 Medical Mask
    K202647 Surgical Mask
    K210030 Medical Surgical Mask
    K210007 Face Mask
    K202607 Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs
    K202387 Disposable Surgical Face Mask
    K201853 Naton Disposable Surgical Face Mask
    K203646 Disposable Medical Face Mask
    K202759 Disposable medical surgical mask
    K201718 GD Disposable Medical Face Mask
    K201127 DEFEND Ear-loop Face Masks
    K210018 Disposable Medical Mask
    K203012 Surgical Mask
    K202761 Medical Surgical Mask (Non-sterile)
    K202513 Disposable Medical Face Mask-Model FM-04
    K203801 Disposable Surgical Face Mask
    K202655 Disposable Medical Mask
    K210023 Surgical Face Mask
    K203101 Secure Wear USA Surgical Face Mask
    K202424 Surgical Mask-Models CR02-2, CR02
    K202708 Surgical Face Masks
    K201896 ivi N3003 Surgical face Mask, ivi N6006 Surgical mask
    K202191 Surgical Mask
    K203685 Disposable Surgical Face Mask
    K202905 Disposable Face Mask
    K203776 Surgical Masks, Model SNN200640 & MN112
    K202824 BRS Procedure Face Mask
    K202133 Disposable Medical Mask
    K202650 Medical disposable face mask non sterile
    K203064 ICU Health Surgical Mask
    K202628 Disposable Medical Face Mask
    K201095 Sovereign America Surgical Face Mask
    K201624 Spin Care Disposable Protective Mask
    K210487 MIPLNI YK-244 Disposable Surgical Mask
    K201924 Single-Use Surgical Mask
    K201698 Medical Surgical Mask
    K203775 AIC disposable medical mask
    K202548 Surgical Face Mask
    K202411 Surgical Mask
    K202161 Surgical Face Mask
    K210181 Nordiwell Surgical Face Mask
    K202710 Disposable Medical Face Mask
    K202409 Surgical Mask
    K202205 Surgical Face Mask
    K202439 Disposable Medical Face Mask
    K201974 Single-use medical face mask
    K203425 Surgical Mask
    K210225 Surgical Face Mask
    K202137 Disposable medical mask
    K202316 Medical mask (Model: KKF-1A)
    K202214 IFM Surgical Mask Model SM3
    K201852 Surgical Mask-Model Number: Ear Loop, Flat-Pleated
    K203524 Surgical Masks
    K202240 Disposable Surgical Mask/Fluid Resistant Procedure Mask
    K201868 Phyziofit Medical Surgical Mask
    K201182 iMask Disposable Surgical Face Mask
    K203426 Surgical Face Mask (non-sterile)
    K201732 Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
    K202341 Disposable Surgical Mask
    K201545 Surgical Face Mask
    K202605 Standard Procedure Mask, Standard Surgical Mask
    K203265 nPro Surgical Mask
    K210063 Freudenberg Surgical Mask
    K201421 Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
    K202493 Medical Face Mask
    K202627 Medical Face Masks
    K202511 Disposable Medical Surgical Mask
    K202331 Medical Face Mask
    K202323 Disposable Medical Surgical Masks
    K202096 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On
    K202358 Protective Face Mask for Medical Use
    K202640 Surgical Mask
    K202904 Surgical Face Mask
    K202595 Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
    K202107 Medical Protective Mask
    K202314 Procedure face mask (Model: KKF-2A)
    K202843 Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
    K201625 Disposable Medical Surgical Mask
    K202577 Medical Surgical Mask-Model MP002-5, MP002-6
    K202594 Medical Surgical Masks-Non Sterile
    K202491 Disposable Surgical Face Mask
    K202719 Disposable Medical Face Masks
    K202615 Nordiwell Medical Face Mask
    K201754 JianYu Surgical Mask
    K202061 Medical Face mask
    K202211 Disposable Medical Surgical Face Masks
    K202029 Medical Surgical Mask
    K201629 Medical Face Mask
    K201893 Disposable Surgical Mask
    K201729 Medical Mask
    K202069 BASE4 Disposable Medical Mask
    K201622 Medical surgical mask
    K201991 Medical surgical mask
    K202139 Medical surgical mask
    K201601 Medical Face Mask
    K201380 Livocare Surgical Mask
    K202277 Surgical Face Mask
    K202463 Disposable Surgical Mask
    K201691 Single-Use Surgical Mask With Ear Loop
    K202354 Surgical Mask-Model Number CW01
    K201470 Disposable Medical Face Mask
    K201537 Protective Face Mask for Medical Use
    K201517 Plain Surgical Mask
    K201549 Motex Anti-Fog Surgical Face Mask
    K200923 Single-use Surgical Mask
    K201137 Asept Surgical Face Mask
    K201871 Surgical Mask
    K201479 DemeMASK
    K200847 Surgical Face Mask
    K200576 ClearMask Transparent Surgical Face Mask
    K192374 Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
    K191355 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask
    K182515 Surgical Face Mask
    K182514 Surgical Face Mask
    K180874 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
    K172500 Technoweb Surgical Mask
    K173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
    K171162 Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield
    K153409 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
    K160269 Surgical Face Masks (Ear loops and Tie-on)
    K152197 Skypro, SP01 Mask
    K153496 Disposable Surgical Face Mask
    K152561 Communicator Surgical Facemask with Clear Window
    K133070 SURGICAL FACE MASK (Ear Loops and Tie-on)
    K141875 Pasture 60S Surgical Mask
    K141085 WestTec Procedure Facemask;WestTec Surgical Facemask
    K143287 Fluidshield* Surgical Mask with Expanded Chamber
    K142990 Insta-Gard Surgical and Procedure Face Mask
    K140155 SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
    K131879 KC 300 SURGICAL MASK
    K123787 GREENCROSS SURGICAL MASK
    K123115 ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
    K122717 FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
    K111402 KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
    K111343 CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
    K111559 SURGICAL MASKS
    K110027 SURGICAL FACE MASK; SURGICAL FACE MASK
    K110455 KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
    K102713 TIGER FLAT SURGICAL MASK
    K103303 CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
    K093901 SURGICAL FACE MASK
    K100846 IMC SURGICAL FACE MASK
    K101000 WELLMIEN SURGICAL MASK
    K093179 MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
    K100800 TIDI FACEMASK
    K092580 TIDI FACEMASK
    K092012 PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
    K082258 CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR
    K081633 PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
    K070407 DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE
    K063043 SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
    K061864 DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
    K061716 PRESTIGE AMERITECH FACE MASK
    K060776 SURGICAL FACE MASK
    K050689 SURGICAL FACE MASK
    K051291 NON-STERILE SURGICAL MASK
    K043199 SURGICAL FACE MASK
    K042654 PROTECTION PLUS EARLOOP PROCEDURE MASK
    K041047 ULTRADENT CARBON MASK - UPI #342
    K040333 VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
    K022256 SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
    K034015 EARLOOP PROCEDURE MASK
    K030239 MEGATECH SCIENTIFIC FACE MASK
    K031353 SOLUTION FACE MASKS
    K023755 WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD
    K021546 DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
    K021539 DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS
    K021533 DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
    K021076 PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
    K012602 CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
    K011789 PROCEDURE MASKS: PM4-301 AND PM4-304
    K001892 WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
    K001997 WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
    K001893 WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
    K001951 PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
    K992604 HENRY SCHEIN SURGICAL MASK
    K991559 MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
    K990719 EARLOOP FACE MASK
    K984389 TOP WHOLESOME FACE MASK
    K972849 ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
    K972883 ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
    K970835 FACE MASK, SURGICAL MASK, NON-STERILE
    K971744 FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
    K971130 DEFEND FLUID RESISTANT PLEATED MASK
    K964114 DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
    K970440 EKONIC DENTAL/MEDICAL MASK (MD 610)
    K965107 MEDLINE ADMISSION KITS
    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
    K964168 PROCEDURE SPECIFIC KITS
    K963568 MASK SURGICAL
    K964358 AMSEAL SURGICAL FACE MASK
    K964723 RACAL N95 RESIRATOR
    K964722 DELTA N95 RESPIRATOR
    K962654 COMPLEAT SURGICAL MASK
    K962443 N95 FILTERING FACEPIECE
    K962286 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD
    K961217 BODILY FLUID DISPOSAL KIT
    K961402 STS SHIELD WITH MASK
    K960048 EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
    K955382 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
    K955557 FLUID REISISTANT EYESHIELD MASK
    K955556 FLUID RESISTANT MASK
    K955513 SURGICAL MASK (NON-STERILE)
    K953754 GLOBAL HEALTHCARE FACE MASK
    K952961 BODY FLUID BARRIER KIT
    K953102 BLOODBORNE PATHOGEN KIT
    K951913 OVAL SURGICAL FACE MASK
    K952962 EZ-PERSONAL PROTECTION KIT
    K950554 NORTH BLOODBORNE PATHOGEN RESPONSE KIT
    K946001 EMERGENCY RESPONSE SAFETY KIT
    K933683 PENTAX FACE MASK
    K946343 INTEC EXTENDED EYE SHIELD WITH MASK
    K944880 BODILY FLUID DISPOSAL KIT
    K944545 BODY FLUIDS BARRIER KIT
    K940720 BUSSE ISOLATION AND PROCEDURAL MASKS
    K942476 PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069
    K942475 PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351
    K942474 PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000
    K942473 PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592
    K942472 PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123
    K942471 PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777
    K942470 PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315
    K933748 SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD
    K940707 3M SURGICAL MASK WITH FACE SHEILD
    K932834 TECNOL PCM 2000
    K931580 DISPOSABLE SURGICAL MASK (MODIFIED)
    K932133 EYSOTEK
    K932132 EYSOTEK
    K932137 FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR
    K934974 FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD
    K934969 DUALGARD FACE SHIELD
    K934194 BARRIER LASER PLUS FACE MASK
    K920108 BARRIER EXTRA PROTECTION PLUS FACE MASK
    K925185 ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS
    K930067 BUFFALO FILTER SURGICAL MASK
    K920162 TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK
    K915817 TECNOL FLUIDSHIELD INFECTION CONTROL MASK
    K922507 GERSON ISOLAIR APR PARTICULATE SURGICAL MASK
    K922716 SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509
    K920203 TECNOL INFECTION CONTROL MASK
    K920846 CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER
    K920682 PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001
    K914832 SURGICAL APPAREL
    K914412 MASK, SURGICAL, DISPOSABLE
    K913558 RELIABLE CONE STYLE FACE MASK
    K911334 MASK, SURGICAL APPAREL
    K913043 MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
    K911891 FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
    K911907 FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
    K910557 BARRIER* EXTRA PROTECTION PLUS FACE MASK
    K910110 TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK
    K905865 ANTI-FOR SURGICAL FACE MASK
    K910182 3M BRAND EAR LOOP FACE MASK, 2000F
    K905749 SURGICAL FACE MASK
    K905209 SURGICAL MASK
    K903486 MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493
    K902547 THE PROTECTOR II, LASER SURGICAL MASK
    K902546 THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK
    K900665 DRESSING CHANGE KIT
    K900088 MASKS SURGICAL DENTAL
    K896193 TECNOL LAZER(TM) SURGICAL MASK
    K895077 SURGICAL MASK/DENTAL MASK
    K894905 FACE PROTECTION PAK(TM)
    K894516 VISOSHIELD(TM), SURGICAL EYE PROTECTOR
    K893939 ISOLATION MASKS
    K893634 MODIFIED STERILIZATION OF TUR APRONS
    K893417 SURGIFRESH SUB-MICRON MASK NO. 901008-000
    K892451 SAFE-T-FACE DISPOSABLE FACE SHIELD
    K891141 CARERITE FACE MASK
    K891056 SURGICAL CONE MASK
    K891052 SPLASH GUARD GOGGLE
    K891051 SURGICAL FACE MASK-EAR LOOP
    K891409 PRECEPT MICRO-GARD LASER MASK
    K890771 ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
    K890128 FACELOCK FILTER MASK
    K890016 FACE MASK
    K884877 OCUSHIELDS MASKS
    K884929 OCCUSHIELDS
    K884392 KBM DENTAL MASK
    K883827 MASKS, VARIOUS TYPES OF SURGICAL MASKS
    K883705 FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS
    K883658 I-SPOSE EYE SHIELD
    K883828 CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS
    K880534 ZEPHYR
    K882883 C-MASK(FLAT)
    K882882 C-MASK
    K881913 PROTECTO-SHIELD
    K882028 COVERALL SHIELD
    K882027 COMBO-SHIELD
    K882026 ADD-A-SHIELD
    K881910 LABELING CHANGE TO SURGICAL FACE MASK
    K881618 ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
    K881372 ENDICOTT & BEAMAN SUPRA-TEC FACE MASK
    K874894 TECNOL LASER SURGICAL MASK
    K880757 TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD
    K875008 GUARDALL SHIELD
    K880613 ACCO(R) FACE MASK
    K875194 KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001
    K875172 DISPOSABLE SURGICAL FACE MASK
    K873731 SAFETY SHIELD KIT
    K874296 INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER
    K874608 TECNOL FLUID SHIELD SURGICAL MASK
    K872935 ANTI-INFECTION SHIELD
    K873785 TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE
    K873705 CARERITE FACE MASK
    K871558 DENTAL FACE MASKS, POLYESTER
    K870312 WHITE PLUME SURGICAL GAUZE FACE MASK
    K870056 TECNOL CLASSIC CONE MASK
    K851556 OP-FACE MASK(MASQUE DE CHIRUGIE)
    K850247 PERITONEAL DIALYSIS COIL CATHETER
    K831148 HIGH FILTRATION ISO-MASK
    K832281 TWO-PLY PAPER FACE FACE MASK
    K832194 SURGICAL FACE MASK-DISPOSABLE
    K830890 SURGICAL FACE MASK
    K823078 SPUNGUARD FACE MASK
    K822481 MULTIPLE SURGICAL MASK
    K820893 DISPOSABLE SURGICAL FACE MASK
    K813078 CONTURA DISPOS. SURG. FACE MASK
    K812997 FILTER FLOW MASK CAT. #350
    K812996 FILTER FLOW MASK CAT. #300
    K812992 SURGICAL MASK
    K812675 DISPOSABLE SURGICAL FACE MASKS
    K810316 SURGIKOS FACE MASK
    K802373 SURGICAL FACE MASK
    K801036 SURGICAL MASK
    K792110 CONPHAR FACE MASK-STERILE
    K780607 MASK, SURGEONS
    K780609 MASK, ISOLATION
    K780169 MASK, SURGICAL
    K771409 DISP. SURGICAL FACE MASK
    K770513 MASK, SURGICAL, DISP
    K770463 MASK, SURGICAL, FACE, DISPOSABLE
    K760991 SURGINE FACE MASK

    FEI Numbers

    This FDA classification entry is associated with 329 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 329 registration numbers. Click on an entry to view related FDA registrations.