BEUDAMED
    FDA 510(k) Substantially Equivalent 🇮🇩 Indonesia

    LATEX EXAMINATION GLOVES

    K Number: K944778 · Decision Nov 17, 1994
    View on FDA
    Classifications
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    51

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    Basic Information

    Device Name
    LATEX EXAMINATION GLOVES
    K Number
    K944778
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pt. Haloni Jane
    Date Received
    September 27, 1994
    Decision Date
    November 17, 1994
    Product Code
    OPE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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    Other Clearances by Pt. Haloni Jane

    K Number Device Name
    K062955 POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE