Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- ERYDrape, Surgical, Ent2Product Code
- EYXDrape, Pure Latex Sheet, With Self-Retaining Finger Cot2Product Code
- EYYDrape, Urological, Disposable2Product Code
- FXOSuit, Surgical1Product Code
- FXPCover, Shoe, Operating-Room1Product Code
- FXXMask, Surgical2Product Code
- K242502Aurelia Surgical Mask ASTM Level-3 (2130)2Cleared 510(K)
- K240916Surgical Face Mask (Tie on/ Ear loops)2Cleared 510(K)
- K240286PRIMED Surgical Masks and PRIMED Procedure Masks2Cleared 510(K)
- K233723Medical surgical mask2Cleared 510(K)
- K232824FLUIDSHIELD* 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)2Cleared 510(K)
- K232777FLUIDSHIELD* 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)2Cleared 510(K)
- K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)2Cleared 510(K)
- K232812Fluidshield* 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)2Cleared 510(K)
- K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)2Cleared 510(K)
- K232968Grande Medical Masks, Model SF-6002Cleared 510(K)
- K232820HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)2Cleared 510(K)
- K240258Disposable Medical Face Mask (M643BE)2Cleared 510(K)
- K232112R&G Surgical Mask2Cleared 510(K)
- K231719Medical Surgical Mask2Cleared 510(K)
- K232894HALYARD* 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)2Cleared 510(K)
- K232797Hygenix2Cleared 510(K)
- K231005Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 22Cleared 510(K)
- K231155Biodegradable Medical surgical mask2Cleared 510(K)
- K232359Surgical face mask2Cleared 510(K)
- K230380Surgical Face Masks, Model: EFMDS-L50Pn BLU2Cleared 510(K)
- K2316183 Layer Surgical Mask (134252531)2Cleared 510(K)
- K230395Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)2Cleared 510(K)
- K230569Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )2Cleared 510(K)
- K230617Surgical Face Mask (L 175*95mm)2Cleared 510(K)
- K222545Disposable Medical Mask2Cleared 510(K)
- K223823Disposable Surgical Face Mask2Cleared 510(K)
- K223236Medline Surgical Face Mask and Medline Procedural Face Mask2Cleared 510(K)
- K221352Surgical Face Mask2Cleared 510(K)
- K221209PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops2Cleared 510(K)
- K230383Savvy Surgical Mask - Level 32Cleared 510(K)
- K223232Procedure mask/Surgical mask/Face mask2Cleared 510(K)
- K230093Disposable 4 Layers Surgical Face Mask2Cleared 510(K)
- K223686Medical Protective Masks2Cleared 510(K)
- K221682Ideal Med Pro 3-Ply Disposable Face Mask2Cleared 510(K)
- K203380Disposable Surgical Face Mask2Cleared 510(K)
- K222483Surgical Face Mask2Cleared 510(K)
- K222809Medical Disposable Face Masks2Cleared 510(K)
- K213601Surgical Mask2Cleared 510(K)
- K220520PM Excellence SEQUR 100 Surgical Face Mask2Cleared 510(K)
- K222651Surgical Face Mask2Cleared 510(K)
- K2230453-Ply Disposable Medical Mask2Cleared 510(K)
- K223055Disposable Medical Face Mask2Cleared 510(K)
- K223068Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)2Cleared 510(K)
- K223003Banded Face Mask2Cleared 510(K)
- K220302Disposable surgical face mask2Cleared 510(K)
- K203528KNH Surgical Face Mask2Cleared 510(K)
- K222749High Fluid-Resistant Surgical and Procedure Mask2Cleared 510(K)
- K222529Surgical Face Mask2Cleared 510(K)
- K222551Humask Pro Vision, Humask Pro Vision 30002Cleared 510(K)
- K222697Disposable Medical Face Mask (DF3-001)2Cleared 510(K)
- K223270POSE™ Health Care Surgical Mask2Cleared 510(K)
- K212649Disposable Surgical Face Mask2Cleared 510(K)
- K222335Surgical Mask2Cleared 510(K)
- K222266Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)2Cleared 510(K)
- K222204Medical Surgical Mask2Cleared 510(K)
- K221976Surgical Face Mask (Non-sterile)2Cleared 510(K)
- K221534Surgical Face Masks (Ear Loops And Tie-On)2Cleared 510(K)
- K212926AllureTM Surgical Mask2Cleared 510(K)
- K214035LAITEST Medical Face Mask2Cleared 510(K)
- K220944PointCore Surgical Mask2Cleared 510(K)
- K222426Perfetta Moderate Medical Face Mask2Cleared 510(K)
- K221957Savewo ClassicMASK2Cleared 510(K)
- K221038Disposable Medical Masks2Cleared 510(K)
- K220067Medical Surgery Mask, Model:2626-72Cleared 510(K)
- K211771The 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 Mask2Cleared 510(K)
- K203078CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW2Cleared 510(K)
- K221838Surgical Face Mask (HNFM0103)2Cleared 510(K)
- K212273Cross Protection ResQ300 Plus Surgical Face Mask2Cleared 510(K)
- K220876AOK 95A Medical Mask (20200049)2Cleared 510(K)
- K221409Paneffort 3-ply Surgical and Procedural Masks2Cleared 510(K)
- K221196Disposable Medical Face Mask (ear loop)2Cleared 510(K)
- K220777Surgical face mask2Cleared 510(K)
- K221173Surgical Mask (Model: 0868F, 0866F)2Cleared 510(K)
- K220378Sparta 3-Ply Surgical Disposable Face Mask2Cleared 510(K)
- K221272Medical Face Mask2Cleared 510(K)
- K221273Medical Face Mask (M001)2Cleared 510(K)
- K220670Magnum2Cleared 510(K)
- K220377Procedure Mask2Cleared 510(K)
- K220550Disposable Surgical Face Mask (M663BE, M663BT)2Cleared 510(K)
- K221222Surgical Face Mask (HNFM0304)2Cleared 510(K)
- K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)2Cleared 510(K)
- K220191Disposable Face Mask2Cleared 510(K)
- K220532Disposable surgical mask2Cleared 510(K)
- K221134Procedure Mask with Ear Loops and Surgical Mask with Ties2Cleared 510(K)
- K220824Medical Surgical Mask (Planar type)2Cleared 510(K)
- K220194Procedure mask/Surgical mask/Face mask2Cleared 510(K)
- K220749Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP2Cleared 510(K)
- K213001Procedure Mask, Surgical Mask2Cleared 510(K)
- K220487Disposable Medical Face Mask2Cleared 510(K)
- K220512Disposable Surgical Face Mask (M01, M02)2Cleared 510(K)
- K212203Dong Hai Xiang Surgical Mask2Cleared 510(K)
- K210860Comfort Guard Mask, level 1, Comfort Guard Mask, level 32Cleared 510(K)
- K214085Disposable Medical Mask2Cleared 510(K)
- K213450Medical surgical mask (Black mask, Level 1 and Level 3)2Cleared 510(K)
- K213736Medical Face Mask2Cleared 510(K)
- K210422INTAI Surgical Mask (non-sterile)2Cleared 510(K)
- K2206373 Ply Medical Grade Single Use Procedural Disposable Face Mask2Cleared 510(K)
- K220187Medical Surgical Mask (Model: JM92, JM92B)2Cleared 510(K)
- K202903Surgical Face Mask2Cleared 510(K)
- K212726Disposable Medical Surgical Mask2Cleared 510(K)
- K213894DWFritz ASM20002Cleared 510(K)
- K212330Yadu Medical Face Mask (Level 1)2Cleared 510(K)
- K213806Disposable Medical Face Mask2Cleared 510(K)
- K214087Medical Face Mask2Cleared 510(K)
- K213358Surgical Mask2Cleared 510(K)
- K203376ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G2Cleared 510(K)
- K214094ROKI Surgical Mask2Cleared 510(K)
- K213724Medical Surgical Mask2Cleared 510(K)
- K212863Surgical Face Mask2Cleared 510(K)
- K212366Heartland Health Surgical Mask2Cleared 510(K)
- K213617Surgical Face Mask2Cleared 510(K)
- K212120Surgical Masks2Cleared 510(K)
- K212610Surgical Face Mask2Cleared 510(K)
- K210101American-Made Surgical Mask2Cleared 510(K)
- K213347ADI Medical Surgical Face Mask2Cleared 510(K)
- K213970D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply2Cleared 510(K)
- K212111Myflon Surgical Mask Level 32Cleared 510(K)
- K203161Surgical Face Mask2Cleared 510(K)
- K212826Disposable Medical Mask2Cleared 510(K)
- K210679Medical Face Mask2Cleared 510(K)
- K212994Medical Face Mask2Cleared 510(K)
- K213920Kangbeier Surgical Mask (Model: KBR-1001)2Cleared 510(K)
- K211833Disposable Medical Face Mask2Cleared 510(K)
- K212997Surgical Mask2Cleared 510(K)
- K212913Surgical Face Mask2Cleared 510(K)
- K211260Sheng Jing Tang Surgical Mask2Cleared 510(K)
- K212375Disposable Medical Surgical Mask2Cleared 510(K)
- K212299Medical Surgical Mask2Cleared 510(K)
- K213136CPL Surgical Face Mask2Cleared 510(K)
- K202255Skypro, SP02 Mask (3)2Cleared 510(K)
- K210147Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield2Cleared 510(K)
- K211750Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)2Cleared 510(K)
- K212059Surgical Face Mask2Cleared 510(K)
- K210102Topwide Surgical Face Mask2Cleared 510(K)
- K211378LM Surgical Mask Level 3, LM Surgical Mask Level 2,2Cleared 510(K)
- K212944Disposable Surgical Mask2Cleared 510(K)
- K212398Surgical Face Mask (Non-sterile)2Cleared 510(K)
- K212574Surgical Face Mask2Cleared 510(K)
- K210744Surgical Mask2Cleared 510(K)
- K202794Surgical face mask: F-Y1-A2Cleared 510(K)
- K212867Medical Surgical Mask2Cleared 510(K)
- K211487MAF Guard2Cleared 510(K)
- K212302BAYLAB 3-Ply Surgical Mask (BEACON I)2Cleared 510(K)
- K212235Surgical Face Mask2Cleared 510(K)
- K211772PMW01 Procedure Mask Level 12Cleared 510(K)
- K212807Surgical Masks2Cleared 510(K)
- K212740Puravita Medical Fold Flat Surgical Mask2Cleared 510(K)
- K211773Single-use Surgical Mask2Cleared 510(K)
- K211696Disposable Surgical Face Mask2Cleared 510(K)
- K202842Medical surgical mask2Cleared 510(K)
- K211295Surgical Mask (sterile)2Cleared 510(K)
- K211956039 Surgical Face Mask2Cleared 510(K)
- K213406Savvy Mask - Level 3 Surgical Face Mask2Cleared 510(K)
- K212046Impertech Surgical Face Mask2Cleared 510(K)
- K210042Disposable Surgical Mask2Cleared 510(K)
- K212344Surgical Mask2Cleared 510(K)
- K212575Surgical Face Mask2Cleared 510(K)
- K212109Spin Care Disposable Protective Mask Level 32Cleared 510(K)
- K212264Surgical Face mask2Cleared 510(K)
- K212526Surgical Face Mask2Cleared 510(K)
- K211165Medical Face Masks, Model Name:MY0200032Cleared 510(K)
- K212460Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))2Cleared 510(K)
- K202676Disposable Medical Face Mask2Cleared 510(K)
- K212471Medical Face Mask2Cleared 510(K)
- K210222Disposable Medical Mask2Cleared 510(K)
- K212293Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)2Cleared 510(K)
- K212368Surgical Face Mask2Cleared 510(K)
- K210348Disposable Medical Surgical Mask2Cleared 510(K)
- K203565Surgical 3D Mask2Cleared 510(K)
- K212205Medical Protective Masks2Cleared 510(K)
- K210845Disposable Surgical Mask (Model: YYKZ-01)2Cleared 510(K)
- K210813Medical Surgical Mask2Cleared 510(K)
- K210622Single-Use Medical Face Mask2Cleared 510(K)
- K211899Surgical Face Mask2Cleared 510(K)
- K211425Private Stock Labs Surgical Face Mask2Cleared 510(K)
- K210513UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 22Cleared 510(K)
- K211794Disposable surgical mask2Cleared 510(K)
- K210878Surgical Face Mask (Model: CM2006, CM2008, A88)2Cleared 510(K)
- K210908Surgical Mask2Cleared 510(K)
- K211827Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)2Cleared 510(K)
- K211097Banyan USA Surgical Mask Level 32Cleared 510(K)
- K2107723-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)2Cleared 510(K)
- K211751WELLTRUST WT-III Mask with Flat Earloop2Cleared 510(K)
- K203418Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))2Cleared 510(K)
- K203112Disposable Medical Mask2Cleared 510(K)
- K210184Wilson Tech Disposable Medical Face Mask2Cleared 510(K)
- K203455Disposable Medical Mask2Cleared 510(K)
- K211296Surgical face mask2Cleared 510(K)
- K212451Surgical Mask2Cleared 510(K)
- K211832Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask2Cleared 510(K)
- K211762Altor Safety 4-Ply Surgical Mask (Model:62232)2Cleared 510(K)
- K211536Welspun Health Surgical Mask2Cleared 510(K)
- K211255Surgical Mask2Cleared 510(K)
- K202746Surgical mask2Cleared 510(K)
- K211451Disposable Surgical Mask (non sterile)2Cleared 510(K)
- K202745Disposable medical face mask2Cleared 510(K)
- K211576WYZ Surgical Mask2Cleared 510(K)
- K211462Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask2Cleared 510(K)
- K211066Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM32Cleared 510(K)
- K210698ECOMA Level 2 Disposable Surgical Mask with Ear Loops2Cleared 510(K)
- K210256CiRx (R) Surgical Mask2Cleared 510(K)
- K212097Disposable medical surgical mask2Cleared 510(K)
- K211631Surgical Face Mask2Cleared 510(K)
- K211454Surgical mask2Cleared 510(K)
- K211552Surgical mask2Cleared 510(K)
- K211353Medical Face Mask2Cleared 510(K)
- K203152Disposable Face Mask2Cleared 510(K)
- K210643Disposable Surgical Face Mask2Cleared 510(K)
- K211897Surgical Face Mask2Cleared 510(K)
- K203174Disposable Medical Mask2Cleared 510(K)
- K210870MEO Med Disposable Medical Face Mask2Cleared 510(K)
- K211861TAIJI Professional Series Level 3 Surgical Face Mask2Cleared 510(K)
- K211497Surgical Mask2Cleared 510(K)
- K210856Purism Disposable Surgical Mask2Cleared 510(K)
- K210409Disposable Surgical Face Mask2Cleared 510(K)
- K211984MASC Surgical Mask2Cleared 510(K)
- K211363Medical Face Mask2Cleared 510(K)
- K211249Altor Safety 3-Ply Surgical Mask (Model:62222)2Cleared 510(K)
- K210391Single-use medical face mask2Cleared 510(K)
- K210970Single-Use Surgical Mask Model FE2311B2Cleared 510(K)
- K203534Surgical face mask (Model: Flat Ear Loop/CN102)2Cleared 510(K)
- K210761Velguard Surgical Face Mask2Cleared 510(K)
- K211042Disposable Procedural Ear-loop Face Mask2Cleared 510(K)
- K201844Surgical Face Mask, Surgical Mask2Cleared 510(K)
- K210244Disposable Medical Face Mask2Cleared 510(K)
- K210380Medical surgical mask2Cleared 510(K)
- K210267Disposable Surgical Mask2Cleared 510(K)
- K210524Surgical Mask2Cleared 510(K)
- K203591Single-use Medical Face Mask2Cleared 510(K)
- K202954Disposable Surgical Mask2Cleared 510(K)
- K210445Nordiwell Surprotect Face Mask2Cleared 510(K)
- K210840Disposable Surgical Mask2Cleared 510(K)
- K203200Disposable Medical Surgical Face Mask2Cleared 510(K)
- K211520Amerishield Surgical Mask2Cleared 510(K)
- K210518Surgical Face Mask2Cleared 510(K)
- K203732Surgical Face Mask2Cleared 510(K)
- K202714Medical Face Mask2Cleared 510(K)
- K210767Surgical Masks, Model:FE-12Cleared 510(K)
- K210015Surgical Face Mask2Cleared 510(K)
- K203756Disposable Surgical Mask2Cleared 510(K)
- K211062Medical Face Mask2Cleared 510(K)
- K202126Disposable Surgical Mask2Cleared 510(K)
- K210641Disposable Medical Mask2Cleared 510(K)
- K210433Surgical Face Mask (Ear loops and Tie-on)2Cleared 510(K)
- K210372Disposable Surgical Mask2Cleared 510(K)
- K202580Disposable Surgical Mask2Cleared 510(K)
- K203704Surgical face mask2Cleared 510(K)
- K203388Disposable medical mask2Cleared 510(K)
- K202128Allmed Surgical Face Masks (Ear loops)2Cleared 510(K)
- K211440ASM-301 Level 3 Surgical Mask2Cleared 510(K)
- K210429Disposable Surgical Face Mask2Cleared 510(K)
- K210150Disposable Medical mask2Cleared 510(K)
- K203190Surgical Face Mask2Cleared 510(K)
- K211275AirMax Procedure Mask2Cleared 510(K)
- K202899Procedure Mask, Surgical Mask2Cleared 510(K)
- K211105Ear-Friendly Mask2Cleared 510(K)
- K210302Disposable Medical mask2Cleared 510(K)
- K210815Disposable Face Mask2Cleared 510(K)
- K202697United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask2Cleared 510(K)
- K210218SURGICAL MASK, Model Name:C0152Cleared 510(K)
- K210705Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 32Cleared 510(K)
- K2025983 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 32Cleared 510(K)
- K210304Surgical Mask2Cleared 510(K)
- K202457M1 Surgical Face Mask2Cleared 510(K)
- K210020Medical Mask2Cleared 510(K)
- K202647Surgical Mask2Cleared 510(K)
- K210030Medical Surgical Mask2Cleared 510(K)
- K210007Face Mask2Cleared 510(K)
- K202607Surgical 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 pcs2Cleared 510(K)
- K202387Disposable Surgical Face Mask2Cleared 510(K)
- K201853Naton Disposable Surgical Face Mask2Cleared 510(K)
- K203646Disposable Medical Face Mask2Cleared 510(K)
- K202759Disposable medical surgical mask2Cleared 510(K)
- K201718GD Disposable Medical Face Mask2Cleared 510(K)
- K201127DEFEND Ear-loop Face Masks2Cleared 510(K)
- K210018Disposable Medical Mask2Cleared 510(K)
- K203012Surgical Mask2Cleared 510(K)
- K202761Medical Surgical Mask (Non-sterile)2Cleared 510(K)
- K202513Disposable Medical Face Mask-Model FM-042Cleared 510(K)
- K203801Disposable Surgical Face Mask2Cleared 510(K)
- K202655Disposable Medical Mask2Cleared 510(K)
- K210023Surgical Face Mask2Cleared 510(K)
- K203101Secure Wear USA Surgical Face Mask2Cleared 510(K)
- K202424Surgical Mask-Models CR02-2, CR022Cleared 510(K)
- K202708Surgical Face Masks2Cleared 510(K)
- K201896ivi N3003 Surgical face Mask, ivi N6006 Surgical mask2Cleared 510(K)
- K202191Surgical Mask2Cleared 510(K)
- K203685Disposable Surgical Face Mask2Cleared 510(K)
- K202905Disposable Face Mask2Cleared 510(K)
- K203776Surgical Masks, Model SNN200640 & MN1122Cleared 510(K)
- K202824BRS Procedure Face Mask2Cleared 510(K)
- K202133Disposable Medical Mask2Cleared 510(K)
- K202650Medical disposable face mask non sterile2Cleared 510(K)
- K203064ICU Health Surgical Mask2Cleared 510(K)
- K202628Disposable Medical Face Mask2Cleared 510(K)
- K201095Sovereign America Surgical Face Mask2Cleared 510(K)
- K201624Spin Care Disposable Protective Mask2Cleared 510(K)
- K210487MIPLNI YK-244 Disposable Surgical Mask2Cleared 510(K)
- K201924Single-Use Surgical Mask2Cleared 510(K)
- K201698Medical Surgical Mask2Cleared 510(K)
- K203775AIC disposable medical mask2Cleared 510(K)
- K202548Surgical Face Mask2Cleared 510(K)
- K202411Surgical Mask2Cleared 510(K)
- K202161Surgical Face Mask2Cleared 510(K)
- K210181Nordiwell Surgical Face Mask2Cleared 510(K)
- K202710Disposable Medical Face Mask2Cleared 510(K)
- K202409Surgical Mask2Cleared 510(K)
- K202205Surgical Face Mask2Cleared 510(K)
- K202439Disposable Medical Face Mask2Cleared 510(K)
- K201974Single-use medical face mask2Cleared 510(K)
- K203425Surgical Mask2Cleared 510(K)
- K210225Surgical Face Mask2Cleared 510(K)
- K202137Disposable medical mask2Cleared 510(K)
- K202316Medical mask (Model: KKF-1A)2Cleared 510(K)
- K202214IFM Surgical Mask Model SM32Cleared 510(K)
- K201852Surgical Mask-Model Number: Ear Loop, Flat-Pleated2Cleared 510(K)
- K203524Surgical Masks2Cleared 510(K)
- K202240Disposable Surgical Mask/Fluid Resistant Procedure Mask2Cleared 510(K)
- K201868Phyziofit Medical Surgical Mask2Cleared 510(K)
- K201182iMask Disposable Surgical Face Mask2Cleared 510(K)
- K203426Surgical Face Mask (non-sterile)2Cleared 510(K)
- K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On2Cleared 510(K)
- K202341Disposable Surgical Mask2Cleared 510(K)
- K201545Surgical Face Mask2Cleared 510(K)
- K202605Standard Procedure Mask, Standard Surgical Mask2Cleared 510(K)
- K203265nPro Surgical Mask2Cleared 510(K)
- K210063Freudenberg Surgical Mask2Cleared 510(K)
- K201421Dukal 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 Ons2Cleared 510(K)
- K202493Medical Face Mask2Cleared 510(K)
- K202627Medical Face Masks2Cleared 510(K)
- K202511Disposable Medical Surgical Mask2Cleared 510(K)
- K202331Medical Face Mask2Cleared 510(K)
- K202323Disposable Medical Surgical Masks2Cleared 510(K)
- K2020963-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On2Cleared 510(K)
- K202358Protective Face Mask for Medical Use2Cleared 510(K)
- K202640Surgical Mask2Cleared 510(K)
- K202904Surgical Face Mask2Cleared 510(K)
- K202595Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask2Cleared 510(K)
- K202107Medical Protective Mask2Cleared 510(K)
- K202314Procedure face mask (Model: KKF-2A)2Cleared 510(K)
- K202843Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)2Cleared 510(K)
- K201625Disposable Medical Surgical Mask2Cleared 510(K)
- K202577Medical Surgical Mask-Model MP002-5, MP002-62Cleared 510(K)
- K202594Medical Surgical Masks-Non Sterile2Cleared 510(K)
- K202491Disposable Surgical Face Mask2Cleared 510(K)
- K202719Disposable Medical Face Masks2Cleared 510(K)
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- K111343CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS2Cleared 510(K)
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- K110455KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS2Cleared 510(K)
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- K092580TIDI FACEMASK2Cleared 510(K)
- K092012PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-702Cleared 510(K)
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- K070407DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE2Cleared 510(K)
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- K061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 15602Cleared 510(K)
- K061716PRESTIGE AMERITECH FACE MASK2Cleared 510(K)
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- K034015EARLOOP PROCEDURE MASK2Cleared 510(K)
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- K023755WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD2Cleared 510(K)
- K021546DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR2Cleared 510(K)
- K021539DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS2Cleared 510(K)
- K021533DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)2Cleared 510(K)
- K021076PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM2Cleared 510(K)
- K012602CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX2Cleared 510(K)
- K011789PROCEDURE MASKS: PM4-301 AND PM4-3042Cleared 510(K)
- K001892WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)2Cleared 510(K)
- K001997WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)2Cleared 510(K)
- K001893WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)2Cleared 510(K)
- K001951PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-3062Cleared 510(K)
- K992604HENRY SCHEIN SURGICAL MASK2Cleared 510(K)
- K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD2Cleared 510(K)
- K990719EARLOOP FACE MASK2Cleared 510(K)
- K984389TOP WHOLESOME FACE MASK2Cleared 510(K)
- K972849ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)2Cleared 510(K)
- K972883ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)2Cleared 510(K)
- K970835FACE MASK, SURGICAL MASK, NON-STERILE2Cleared 510(K)
- K971744FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)2Cleared 510(K)
- K971130DEFEND FLUID RESISTANT PLEATED MASK2Cleared 510(K)
- K964114DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS2Cleared 510(K)
- K970440EKONIC DENTAL/MEDICAL MASK (MD 610)2Cleared 510(K)
- K965107MEDLINE ADMISSION KITS2Cleared 510(K)
- K9650433M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE2Cleared 510(K)
- K964168PROCEDURE SPECIFIC KITS2Cleared 510(K)
- K963568MASK SURGICAL2Cleared 510(K)
- K964358AMSEAL SURGICAL FACE MASK2Cleared 510(K)
- K964723RACAL N95 RESIRATOR2Cleared 510(K)
- K964722DELTA N95 RESPIRATOR2Cleared 510(K)
- K962654COMPLEAT SURGICAL MASK2Cleared 510(K)
- K962443N95 FILTERING FACEPIECE2Cleared 510(K)
- K9622862505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD2Cleared 510(K)
- K961217BODILY FLUID DISPOSAL KIT2Cleared 510(K)
- K961402STS SHIELD WITH MASK2Cleared 510(K)
- K960048EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS2Cleared 510(K)
- K9553823M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N952Cleared 510(K)
- K955556FLUID RESISTANT MASK2Cleared 510(K)
- K955557FLUID REISISTANT EYESHIELD MASK2Cleared 510(K)
- K955513SURGICAL MASK (NON-STERILE)2Cleared 510(K)
- K953754GLOBAL HEALTHCARE FACE MASK2Cleared 510(K)
- K952961BODY FLUID BARRIER KIT2Cleared 510(K)
- K953102BLOODBORNE PATHOGEN KIT2Cleared 510(K)
- K951913OVAL SURGICAL FACE MASK2Cleared 510(K)
- K952962EZ-PERSONAL PROTECTION KIT2Cleared 510(K)
- K950554NORTH BLOODBORNE PATHOGEN RESPONSE KIT2Cleared 510(K)
- K946001EMERGENCY RESPONSE SAFETY KIT2Cleared 510(K)
- K933683PENTAX FACE MASK2Cleared 510(K)
- K946343INTEC EXTENDED EYE SHIELD WITH MASK2Cleared 510(K)
- K944880BODILY FLUID DISPOSAL KIT2Cleared 510(K)
- K944545BODY FLUIDS BARRIER KIT2Cleared 510(K)
- K940720BUSSE ISOLATION AND PROCEDURAL MASKS2Cleared 510(K)
- K942475PROTECTAIDE PERSONAL PROTECTION PACK NO. 123512Cleared 510(K)
- K942476PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B30692Cleared 510(K)
- K942474PROTECTAIDE PERSONAL PROTECTION PACK NO. 180002Cleared 510(K)
- K942471PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 297772Cleared 510(K)
- K942470PROTECTAIDE PERSONAL PROTECTION PACK NO. 083152Cleared 510(K)
- K942473PROTECTAIDE PERSONAL PROTECTION PACK NO. 245922Cleared 510(K)
- K942472PROTECTAIDE PERSONAL PROTECTION PACK NO. 261232Cleared 510(K)
- K933748SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD2Cleared 510(K)
- K9407073M SURGICAL MASK WITH FACE SHEILD2Cleared 510(K)
- K932834TECNOL PCM 20002Cleared 510(K)
- K931580DISPOSABLE SURGICAL MASK (MODIFIED)2Cleared 510(K)
- K932133EYSOTEK2Cleared 510(K)
- K932132EYSOTEK2Cleared 510(K)
- K932137FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR2Cleared 510(K)
- K934974FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD2Cleared 510(K)
- K934969DUALGARD FACE SHIELD2Cleared 510(K)
- K934194BARRIER LASER PLUS FACE MASK2Cleared 510(K)
- K920108BARRIER EXTRA PROTECTION PLUS FACE MASK2Cleared 510(K)
- K925185ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS2Cleared 510(K)
- K930067BUFFALO FILTER SURGICAL MASK2Cleared 510(K)
- K920162TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK2Cleared 510(K)
- K915817TECNOL FLUIDSHIELD INFECTION CONTROL MASK2Cleared 510(K)
- K922507GERSON ISOLAIR APR PARTICULATE SURGICAL MASK2Cleared 510(K)
- K922716SPLASH SHIELD # 4505, 4507, PARASHIELD # 45092Cleared 510(K)
- K920203TECNOL INFECTION CONTROL MASK2Cleared 510(K)
- K920846CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER2Cleared 510(K)
- K920682PHOENIX STERI-TECH STERILE DENTAL PACK GEN-100012Cleared 510(K)
- K914832SURGICAL APPAREL2Cleared 510(K)
- K914412MASK, SURGICAL, DISPOSABLE2Cleared 510(K)
- K913558RELIABLE CONE STYLE FACE MASK2Cleared 510(K)
- K911334MASK, SURGICAL APPAREL2Cleared 510(K)
- K913043MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS2Cleared 510(K)
- K911891FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK2Cleared 510(K)
- K911907FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS2Cleared 510(K)
- K910557BARRIER* EXTRA PROTECTION PLUS FACE MASK2Cleared 510(K)
- K910110TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK2Cleared 510(K)
- K905865ANTI-FOR SURGICAL FACE MASK2Cleared 510(K)
- K9101823M BRAND EAR LOOP FACE MASK, 2000F2Cleared 510(K)
- K905749SURGICAL FACE MASK2Cleared 510(K)
- K905209SURGICAL MASK2Cleared 510(K)
- K903486MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-74932Cleared 510(K)
- K902547THE PROTECTOR II, LASER SURGICAL MASK2Cleared 510(K)
- K902546THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK2Cleared 510(K)
- K900665DRESSING CHANGE KIT2Cleared 510(K)
- K900088MASKS SURGICAL DENTAL2Cleared 510(K)
- K896193TECNOL LAZER(TM) SURGICAL MASK2Cleared 510(K)
- K895077SURGICAL MASK/DENTAL MASK2Cleared 510(K)
- K894905FACE PROTECTION PAK(TM)2Cleared 510(K)
- K894516VISOSHIELD(TM), SURGICAL EYE PROTECTOR2Cleared 510(K)
- K893939ISOLATION MASKS2Cleared 510(K)
- K893634MODIFIED STERILIZATION OF TUR APRONS2Cleared 510(K)
- K893417SURGIFRESH SUB-MICRON MASK NO. 901008-0002Cleared 510(K)
- K892451SAFE-T-FACE DISPOSABLE FACE SHIELD2Cleared 510(K)
- K891141CARERITE FACE MASK2Cleared 510(K)
- K891051SURGICAL FACE MASK-EAR LOOP2Cleared 510(K)
- K891056SURGICAL CONE MASK2Cleared 510(K)
- K891052SPLASH GUARD GOGGLE2Cleared 510(K)
- K891409PRECEPT MICRO-GARD LASER MASK2Cleared 510(K)
- K890771ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK2Cleared 510(K)
- K890128FACELOCK FILTER MASK2Cleared 510(K)
- K890016FACE MASK2Cleared 510(K)
- K884877OCUSHIELDS MASKS2Cleared 510(K)
- K884929OCCUSHIELDS2Cleared 510(K)
- K884392KBM DENTAL MASK2Cleared 510(K)
- K883827MASKS, VARIOUS TYPES OF SURGICAL MASKS2Cleared 510(K)
- K883705FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS2Cleared 510(K)
- K883658I-SPOSE EYE SHIELD2Cleared 510(K)
- K883828CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS2Cleared 510(K)
- K880534ZEPHYR2Cleared 510(K)
- K882883C-MASK(FLAT)2Cleared 510(K)
- K882882C-MASK2Cleared 510(K)
- K881913PROTECTO-SHIELD2Cleared 510(K)
- K882028COVERALL SHIELD2Cleared 510(K)
- K882027COMBO-SHIELD2Cleared 510(K)
- K882026ADD-A-SHIELD2Cleared 510(K)
- K881910LABELING CHANGE TO SURGICAL FACE MASK2Cleared 510(K)
- K881618ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK2Cleared 510(K)
- K881372ENDICOTT & BEAMAN SUPRA-TEC FACE MASK2Cleared 510(K)
- K874894TECNOL LASER SURGICAL MASK2Cleared 510(K)
- K880757TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD2Cleared 510(K)
- K875008GUARDALL SHIELD2Cleared 510(K)
- K880613ACCO(R) FACE MASK2Cleared 510(K)
- K875194KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 570012Cleared 510(K)
- K875172DISPOSABLE SURGICAL FACE MASK2Cleared 510(K)
- K873731SAFETY SHIELD KIT2Cleared 510(K)
- K874296INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER2Cleared 510(K)
- K874608TECNOL FLUID SHIELD SURGICAL MASK2Cleared 510(K)
- K872935ANTI-INFECTION SHIELD2Cleared 510(K)
- K873785TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE2Cleared 510(K)
- K873705CARERITE FACE MASK2Cleared 510(K)
- K871558DENTAL FACE MASKS, POLYESTER2Cleared 510(K)
- K870312WHITE PLUME SURGICAL GAUZE FACE MASK2Cleared 510(K)
- K870056TECNOL CLASSIC CONE MASK2Cleared 510(K)
- K851556OP-FACE MASK(MASQUE DE CHIRUGIE)2Cleared 510(K)
- K850247PERITONEAL DIALYSIS COIL CATHETER2Cleared 510(K)
- K831148HIGH FILTRATION ISO-MASK2Cleared 510(K)
- K832281TWO-PLY PAPER FACE FACE MASK2Cleared 510(K)
- K832194SURGICAL FACE MASK-DISPOSABLE2Cleared 510(K)
- K830890SURGICAL FACE MASK2Cleared 510(K)
- K823078SPUNGUARD FACE MASK2Cleared 510(K)
- K822481MULTIPLE SURGICAL MASK2Cleared 510(K)
- K820893DISPOSABLE SURGICAL FACE MASK2Cleared 510(K)
- K813078CONTURA DISPOS. SURG. FACE MASK2Cleared 510(K)
- K812997FILTER FLOW MASK CAT. #3502Cleared 510(K)
- K812996FILTER FLOW MASK CAT. #3002Cleared 510(K)
- K812992SURGICAL MASK2Cleared 510(K)
- K812675DISPOSABLE SURGICAL FACE MASKS2Cleared 510(K)
- K810316SURGIKOS FACE MASK2Cleared 510(K)
- K802373SURGICAL FACE MASK2Cleared 510(K)
- K801036SURGICAL MASK2Cleared 510(K)
- K792110CONPHAR FACE MASK-STERILE2Cleared 510(K)
- K780607MASK, SURGEONS2Cleared 510(K)
- K780609MASK, ISOLATION2Cleared 510(K)
- K780169MASK, SURGICAL2Cleared 510(K)
- K771409DISP. SURGICAL FACE MASK2Cleared 510(K)
- K770513MASK, SURGICAL, DISP2Cleared 510(K)
- K770463MASK, SURGICAL, FACE, DISPOSABLE2Cleared 510(K)
- K760991SURGINE FACE MASK2Cleared 510(K)
- FXYHood, Surgical2Product Code
- FXZHelmet, Surgical1Product Code
- FYAGown, Surgical2Product Code
- FYBGown, Patient2Product Code
- FYCGown, Isolation, Surgical2Product Code
- HMTDrape, Patient, Ophthalmic2Product Code
- HMWDrape, Microscope, Ophthalmic2Product Code
- KGOSurgeon'S Gloves1Product Code
- KGQCream, Gloving, Surgeon'S1Product Code
- KGTDrape, Adhesive, Aerosol1Product Code
- KKXDrape, Surgical2Product Code
- LGXTable, Examination, Medical, Powered1Product Code
- LYUAccessory, Surgical Apparel1Product Code
- MACDecontamination Kit1Product Code
- MMPCover, Barrier, Protective2Product Code
- MSHRespirator, Surgical2Product Code
- NZPSealant, Microbial2Product Code
- OEANon-Surgical Isolation Gown1Product Code
- OKFBody Fluid Disposal Kit2Product Code
- OKGBody Fluid Clean Up Kit2Product Code
- OKHBody Fluids Barrier Kit2Product Code
- OKIEmergency Response Safety Kit2Product Code
- ONTN95 Respirator With Antimicrobial/Antiviral Agent2Product Code
- OPAPowder-Free Non-Natural Rubber Latex Surgeon'S Gloves1Product Code
- OUKSurgical Mask With Antimicrobial/Antiviral Agent2Product Code
- OVRKit, First Aid, Talking1Product Code
- OXZPediatric/Child Facemask2Product Code
- PIRMercy Tape 2d And 3d Models1Product Code
- PLYAntimicrobial Drapes2Product Code
- PQMSurgical Smoke Precipitator2Product Code
- QBWSurgical Apparel With Material Claims2Product Code
- QMXLabel Or Tag, Non-Sterile1Product Code
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection2Product Code
- QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SPUNGUARD FACE MASK
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K823078
- 510(k) Type
- Traditional
- Applicant
- KIMBERLY-CLARK CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/7/1983
- Days to Decision
- 80 days