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510(k) Data Aggregation

    K Number
    K221534
    Device Name
    Surgical Face Masks (Ear Loops And Tie-On)
    Manufacturer
    San-M Package Co., Ltd.
    Date Cleared
    2022-09-16

    (112 days)

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

    San-M Package Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical face masks are 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. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.
    Device Description
    The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polyester/polypropylene). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.
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    K Number
    K160269
    Device Name
    Surgical Face Masks (Ear loops and Tie-on)
    Manufacturer
    SAN-M PACKAGE CO., LTD.
    Date Cleared
    2016-09-06

    (217 days)

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

    SAN-M PACKAGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided nonsterile.
    Device Description
    The Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
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    K Number
    K160271
    Device Name
    N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
    Manufacturer
    SAN-M PACKAGE CO., LTD.
    Date Cleared
    2016-07-15

    (164 days)

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

    SAN-M PACKAGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouchedshaped respirators when worn. The flat-folded masks are composed of four layers of materials consisting of polypropylene and polyethylene (inner layer), polypropylene meltblown (two filter layers), and polypropylene spunbond (outer layer). The masks contain a conformable nose clamp enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, polyurethane elastic headband not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in orange or white.
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