BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    LATEX EXAMINATION GLOVE

    K Number: K945490 · Decision Dec 8, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    LATEX EXAMINATION GLOVE
    K Number
    K945490
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Masif Healthcare Products Sdn. Bhd.
    Date Received
    November 8, 1994
    Decision Date
    December 8, 1994
    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 Masif Healthcare Products Sdn. Bhd.

    K Number Device Name
    K000377 MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
    K942877 EXAMINATION GLOVES
    K893767 DISPOSABLE LATEX EXAMINATION GLOVES