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510(k) Data Aggregation

    K Number
    K201549
    Device Name
    Motex Anti-Fog Surgical Face Mask
    Manufacturer
    Modern Healthcare Corp.
    Date Cleared
    2020-08-26

    (78 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Modern Healthcare Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Motex Anti-Fog Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
    Device Description
    The Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop, is flat pleated 3-ply device, which consists of four layers, i.e., Inner layer (Bicomponent thermal-bonded nonwoven, Polypropylene / Polyethylene, PP/PE), Filter layer (Polypropylene Melt-blown), Outer layer (Polypropylene Spunbond, blue/ green/ white/ pink color) and Anti-Fog films (EP coated Polyethylene). Each mask contains tie-on strips or elastic ear loops and of steel wire coated with Polyethylene resin to secure the mask fit over the user's mouth and nose. The dimensions of each mask are length 165±5 mm and width 95±2 mm.
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    K Number
    K191898
    Device Name
    Sterile Latex Powder-Free Surgical Gloves
    Manufacturer
    Modern Healthcare Corp.
    Date Cleared
    2019-12-18

    (155 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Modern Healthcare Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
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    K Number
    K063043
    Device Name
    SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
    Manufacturer
    MODERN HEALTHCARE CORP.
    Date Cleared
    2007-03-21

    (169 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MODERN HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.
    Device Description
    Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop, are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops and / or strip. The nosepiece for all Modern Healthcare Corp. Surgical Face Mask is malleable aluminum wire. All the materials used in the construction of the Modern Healthcare Corp. Surgical Face Mask are being used in currently marked devices.
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