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510(k) Data Aggregation

    K Number
    K240258
    Device Name
    Disposable Medical Face Mask (M643BE)
    Date Cleared
    2024-04-18

    (78 days)

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

    Makrite Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
    Device Description
    The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch. The body of the mask is composed of three layers: the inner (3rd layer) and outer (1st layers are made of spun-bond polypropylene, the middle (2nd layer) is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex. Each mask contains ear loops to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex. The Disposable Medical Face Masks are sold and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks.
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    K Number
    K220550
    Device Name
    Disposable Surgical Face Mask (M663BE, M663BT)
    Date Cleared
    2022-06-14

    (109 days)

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

    MAKRITE INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The Disposable Surgical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch. The body of the mask is composed of four layers: the inner(4th layer) and outer(1st layers are made of spun-bond polypropylene, the 2nd layer is made of polyethylene film and the 3rd layer is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex, and the ties are made of spun-bond polypropylene. Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex. The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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    K Number
    K020474
    Device Name
    MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
    Date Cleared
    2002-07-23

    (161 days)

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

    MAKRITE INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask is a no fiberglass, fluid resistant single-use mask intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. This device also meets CDC Guidelines for TB Exposure Control.
    Device Description
    The Makrite Type N95 Healthcare Particulate Respirator and Surgical Mask Model 910-N95 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside noseviece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.
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