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

    PRE POWDERED LATEX EXAMINATION GLOVES

    K Number: K954487 · Decision Mar 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    170

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    Basic Information

    Device Name
    PRE POWDERED LATEX EXAMINATION GLOVES
    K Number
    K954487
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ganz Industries Sdn. Bhd.
    Date Received
    September 27, 1995
    Decision Date
    March 15, 1996
    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 Ganz Industries Sdn. Bhd.

    K Number Device Name
    K945506 ACRYLIC DIPPED LATEX EXAMINATION GLOVES
    K945504 ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE
    K945505 ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE