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    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    LATEX (POWDER FREE) LOW PROTEIN

    K Number: K974853 · Decision Feb 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    7
    Review Days
    42

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    Basic Information

    Device Name
    LATEX (POWDER FREE) LOW PROTEIN
    K Number
    K974853
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    P.T. Healthcare Glovindo
    Date Received
    December 29, 1997
    Decision Date
    February 9, 1998
    Product Code
    LYY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYY Latex Patient Examination Glove

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    Other Clearances by P.T. Healthcare Glovindo

    K Number Device Name
    K021659 PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)
    K010232 PRE-POWDERED NITRILE EXAMINATION GLOVES
    K010233 POWDER FREE NITRILE EXAMINATION GLOVES
    K000838 DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K931406 POWDER-FREE PATIENT EXAMINATION GLOVES
    K930995 POWDERED EXAMINATION GLOVES