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510(k) Data Aggregation

    K Number
    K233740
    Device Name
    Black Nitrile Powder Free Patient Examination Glove, Non Sterile
    Date Cleared
    2024-02-13

    (83 days)

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

    W.A. Rubbermate Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
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    K Number
    K110418
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES
    Date Cleared
    2011-07-13

    (149 days)

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

    W.A. RUBBERMATE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purpose to provide barrier against potentially infectious materials and other contaminants.
    Device Description
    Powder Free Nitrile Examination Gloves is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D 6319 - 10 Standard Specification for Nitrile Examination Gloves for Medical Application¹. They are made from nitrile compound(dispersion of butadiene acrylonitrile copolymer. They are powder free gloves.
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    K Number
    K021041
    Device Name
    WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
    Date Cleared
    2002-07-30

    (120 days)

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

    W.A. RUBBERMATE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WA Rubbermate Powder-Free Latex Examination Gloves are a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    WA Rubbermate Powder Free Latex Examination Gloves
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    K Number
    K971200
    Device Name
    W.A.
    Date Cleared
    1997-08-29

    (150 days)

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

    W.A. RUBBERMATE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
    Device Description
    Powder Free Latex Patient Examination Gloves
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