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510(k) Data Aggregation

    K Number
    K060776
    Device Name
    SURGICAL FACE MASK
    Manufacturer
    HONG YA NON-WOVEN PRODUCTS CO., LTD.
    Date Cleared
    2006-05-25

    (64 days)

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

    HONG YA NON-WOVEN PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Face Mask is Device that is 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 fluids and particulate material.
    Device Description
    Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded I mk) are nat produce o psy (a a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) is malleable aluminum wire. All the materials used in the construction of the Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are being used in currently marked devices.
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    K Number
    K043199
    Device Name
    SURGICAL FACE MASK
    Manufacturer
    HONG YA NON-WOVEN PRODUCTS CO., LTD.
    Date Cleared
    2005-02-16

    (90 days)

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

    HONG YA NON-WOVEN PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Face Mask is device that is 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 fluids and particulate material.
    Device Description
    Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is flat pleated 3-ply masks with an inner and outer layer (spunbonded polypropylene) that sandwich a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is malleable aluminum wire. All the material used in the construction of the Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) are being used in currently marked devices.
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