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510(k) Data Aggregation

    K Number
    K202594
    Device Name
    Medical Surgical Masks-Non Sterile
    Manufacturer
    Shandong T&F Nonwoven Co., LTD
    Date Cleared
    2021-01-06

    (120 days)

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

    Shandong T&F Nonwoven Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Surgical Masks-Non Sterile is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile is 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 Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile is 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. The proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric. The Medical Surgical Masks-Non Sterile is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with 30% polyamide and 70% polyurethane. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
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    K Number
    K120230
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE
    Manufacturer
    SHANDONG TAIXIANG MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2012-07-27

    (184 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANDONG TAIXIANG MEDICAL PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
    Device Description
    A Powder-Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880,6250). Our Powder-Free Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250. Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
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