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510(k) Data Aggregation

    K Number
    K072300
    Device Name
    POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM
    Date Cleared
    2008-05-16

    (273 days)

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

    PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined.
    Device Description
    Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves with a Protein Labeling Claim (containing a 100 micrograms or less of total water extractable protein per gram) and made from Allotex an Enzyme Treated Natural Rubber Latex.
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    K Number
    K032201
    Device Name
    RUBBERCARE POWDERED LATEX EXAMINATION GLOVES
    Date Cleared
    2003-10-10

    (84 days)

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

    PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RubberCare powdered latex examination glove is 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
    It is made from natural rubber latex using USP cornstarch as donning powder. The manufacturing process includes pre and post leaching stages to remove residual chemicals and water-soluble proteins. The extent of protein removal is within the limit of the ASTM D3578-01a24 recommended limits for both powder and water-soluble protein.
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    K Number
    K002111
    Device Name
    RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI
    Date Cleared
    2000-09-08

    (58 days)

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

    PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002112
    Device Name
    RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE
    Date Cleared
    2000-08-14

    (33 days)

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

    PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002114
    Device Name
    RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER
    Date Cleared
    2000-08-11

    (30 days)

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

    PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K994201
    Device Name
    RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    Date Cleared
    2000-02-07

    (56 days)

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

    PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined. It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.
    Device Description
    It is the powder-free variation of the class II latex patient examination gloves made by washing the gloves in a chlorine solution followed by an effective chemical removal and acid neutralization steps. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive or allergic to the powdered version of the same gloves.
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