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510(k) Data Aggregation

    K Number
    K984449
    Device Name
    NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1999-03-19

    (95 days)

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

    PT. IRAMA DINAMIKA LATEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is disposable device intended for mediod purposes that is donned by the user on the hands prevent possible contamination between patient and examiner.
    Device Description
    Colored and Flavored Pre-powdered Latex Pattent Examination Gloves , P.ok - Tulli-Feath, Brice - River , Gram - pipero - pipermint , Lives , P. Contains is megro on Tess af Tual City & Charler experiment , States , policings
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    K Number
    K981064
    Device Name
    POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1998-11-05

    (227 days)

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

    PT. IRAMA DINAMIKA LATEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a disposable patient examination glove made of synthetic rubber intended for medical purposes. It is donned by the user as protection against possible contamination when examining a patient.
    Device Description
    Powderfree Chloroprene Flavored and Colored Patient Examination Gloves
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    K Number
    K980848
    Device Name
    HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1998-04-28

    (55 days)

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

    PT. IRAMA DINAMIKA LATEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is donned by doctors and healthcare workers as protection against possible infection/contamination when examining a patient.
    Device Description
    Not Found
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    K Number
    K972306
    Device Name
    POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1997-09-12

    (85 days)

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

    PT. IRAMA DINAMIKA LATEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is donned by doctors and healthcare workers as protection against possible infection/contamination when examining a patient.
    Device Description
    Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves.
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    K Number
    K965155
    Device Name
    LATEX EXAM GLOVES
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1997-03-05

    (72 days)

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

    PT. IRAMA DINAMIKA LATEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962518
    Device Name
    NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1996-12-19

    (175 days)

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

    PT. IRAMA DINAMIKA LATEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963771
    Device Name
    CHLOROPRENE EXAM GLOVES
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1996-12-19

    (91 days)

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

    PT. IRAMA DINAMIKA LATEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960315
    Device Name
    FLAVORED LATEX PATIENT EXAMINATION
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1996-11-20

    (302 days)

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

    PT. IRAMA DINAMIKA LATEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K953462
    Device Name
    PATIENT EXAMINATION GLOVES
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1996-01-04

    (164 days)

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

    PT. IRAMA DINAMIKA LATEX

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

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