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510(k) Data Aggregation

    K Number
    K221185
    Device Name
    TC Gloves
    Date Cleared
    2022-06-22

    (58 days)

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

    Thanh Cong Pharmaceutical and Trading Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TC Gloves Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    TC Gloves Powder Free Latex Examination Gloves is a Class I device bearing the product code LYY (21CFR 880.6250). They meet all the current specifications listed under the ASTM D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. These gloves are white in color having Finger Texture / Ambidextrous and are powder free. The product is non-sterile.
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    K Number
    K221186
    Device Name
    TC Gloves
    Date Cleared
    2022-06-16

    (52 days)

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

    Thanh Cong Pharmaceutical and Trading Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TC Gloves- Powder Free Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    TC Gloves- Powder Free Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous, Single use and are powder free. The product is non-sterile. Sizes available - S, M, L and XL.
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