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510(k) Data Aggregation

    K Number
    K212408
    Device Name
    Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
    Manufacturer
    Pt. Maja Agung Latexindo
    Date Cleared
    2022-05-18

    (288 days)

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

    Pt. Maja Agung Latexindo

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate.
    Device Description
    The Powder Free Nitrile Examination Gloves, Blue Color, Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between patient and examiner. The gloves are ambidextrous, i.e. can be worn on right hand or left hand. The gloves are manufactured from nitrile synthetic rubber. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate per ASTM D6978-05(2019).
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    K Number
    K161099
    Device Name
    Powder Free Nitrile Examination Gloves, Black
    Manufacturer
    PT. MAJA AGUNG LATEXINDO
    Date Cleared
    2017-02-23

    (310 days)

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

    PT. MAJA AGUNG LATEXINDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Nitrile Examination Gloves, Black 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
    The proposed device is a Powder Free Nitrile Examination Glove. The glove is available in one color: Black. The proposed device is non-sterile. The Powder Free Nitrile Examination Gloves, Black meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K081488
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
    Manufacturer
    PT. MAJA AGUNG LATEXINDO
    Date Cleared
    2008-08-28

    (92 days)

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

    PT. MAJA AGUNG LATEXINDO

    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 hand or finger to prevent contamination between patient and examiner.
    Device Description
    A powder-free patient 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.
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    K Number
    K062709
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES, BLACK
    Manufacturer
    PT. MAJA AGUNG LATEXINDO
    Date Cleared
    2006-12-06

    (86 days)

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

    PT. MAJA AGUNG LATEXINDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder free Latex Examination Gloves, BLACK
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    K Number
    K020040
    Device Name
    LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
    Manufacturer
    PT. MAJA AGUNG LATEXINDO
    Date Cleared
    2002-08-01

    (206 days)

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

    PT. MAJA AGUNG LATEXINDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
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    K Number
    K013996
    Device Name
    LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE
    Manufacturer
    PT. MAJA AGUNG LATEXINDO
    Date Cleared
    2002-02-26

    (85 days)

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

    PT. MAJA AGUNG LATEXINDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners A sterile latex powderfree examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
    Device Description
    Latex Powder free Sterile Examination Gloves
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