BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇱 Mali

    PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)

    K Number: K934133 · Decision Jan 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    3
    Review Days
    142

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)
    K Number
    K934133
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Supergrade Healthcare Products Sdn. Bhd.
    Date Received
    August 18, 1993
    Decision Date
    January 7, 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 Supergrade Healthcare Products Sdn. Bhd.

    K Number Device Name
    K014134 POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
    K891232 PATIENT EXAMINATION GLOVES