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510(k) Data Aggregation

    K Number
    K211515
    Device Name
    Nitrile Examination Gloves
    Manufacturer
    Beijing Reagent Latex Products Co., Ltd.
    Date Cleared
    2021-08-24

    (99 days)

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

    Beijing Reagent Latex Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    The Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are powder-free Class I patient examination gloves are manufactured from nitrile and are blue in color. The examination gloves are intended for medical purpose, will be worn on the examiner's hand, and will be available in four sizes (Small, Medium, Large, and Extra-Large).
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    K Number
    K062797
    Device Name
    POWDERED LATEX SURGICAL GLOVE
    Manufacturer
    BEIJING REAGENT LATEX PRODUCTS CO., LTD.
    Date Cleared
    2007-04-11

    (204 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEIJING REAGENT LATEX PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Powdered Latex Surgical Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical setting, to provide a barner against potentially infectious materials and other contaminants.
    Device Description
    Powdered Latex Surgeon's Glove
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    K Number
    K012104
    Device Name
    SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
    Manufacturer
    BEIJING REAGENT LATEX PRODUCTS CO., LTD.
    Date Cleared
    2001-08-21

    (47 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEIJING REAGENT LATEX PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Powder Free Latex Surgical Glove is a disposable device intended in surgical settings for medical purpose that is worn on the hand to provide a barrier against potentially infectious materials and other contaminants. A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by the are and A surgeon's grove 15 a device intraction wound from contamination. (21CFR 878.4460)
    Device Description
    Class I Surgeon's Glove (Powder Free) 79KGO that meets all the requirement of ASTM D3577.
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    K Number
    K010947
    Device Name
    SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    BEIJING REAGENT LATEX PRODUCTS CO., LTD.
    Date Cleared
    2001-05-25

    (57 days)

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

    BEIJING REAGENT LATEX PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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