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510(k) Data Aggregation

    K Number
    K211003
    Device Name
    SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
    Manufacturer
    Showa Best Glove, Inc.
    Date Cleared
    2022-01-19

    (292 days)

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

    Showa Best Glove, Inc

    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 on the examiner's hands or fingers to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
    Device Description
    The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a Nitrile Butadiene Rubber, blue in color, powder free and non-sterile (per 21 CFR Part 880.6250, class I). The device meets all the specifications in ASTM D6319-10. Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs. The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is designed to be used for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between the patient and the examiner (product code LZA). In addition, these gloves were tested for use with chemotherapy drugs (product code LZC) in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
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    K Number
    K190159
    Device Name
    Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
    Manufacturer
    Showa Best Glove, Inc.
    Date Cleared
    2019-05-06

    (96 days)

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

    Showa Best Glove, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
    Device Description
    The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. The gloves are single use only, supplied in a nonsterile state, and come in six (6) sizes: XS, S, M, L, XL, and XXL. The gloves are made of Nitrile Butadiene Rubber, designed, and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Their physical and performance characteristics meet all requirements of ASTM D6319-10. The gloves are powder-free and meet the requirements of ASTM D6124-06. No powder is used during any stage of manufacturing. Rather, the gloves are manufactured using online chlorination - a process wherein the examination gloves are dipped in a dilute chlorine solution to reduce surface friction. More specifically, through the chlorination reaction, the compound is stabilized and further cross-linked and the gloves' surface becomes hardened and smooth, thereby providing the gloves with good donning properties. The gloves then are removed from the chlorination solution and neutralized in an aqueous ammonia solution and washed until any residual chlorine is removed, resulting in the gloves' surface pH being similar to that of water. Once the wash process is completed, the reactive material is removed, thus ceasing the chlorination process.
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    K Number
    K180467
    Device Name
    SBG Blue Nitrile Powder Free Medical Examination Glove
    Manufacturer
    Showa Best Glove, Inc
    Date Cleared
    2018-10-10

    (231 days)

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

    Showa Best Glove, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
    Device Description
    The SBG Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a nitrile latex compound. Blue in color, powder free and non-sterile.
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    K Number
    K180468
    Device Name
    SBG Black Nitrile Powder Free Medical Examination Glove
    Manufacturer
    Showa Best Glove, Inc.
    Date Cleared
    2018-10-10

    (231 days)

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

    Showa Best Glove, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
    Device Description
    The SBG Black Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a nitrile latex compound, black in color, powder free and non-sterile.
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