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

    HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES

    K Number: K925363 · Decision Jul 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    257

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    Basic Information

    Device Name
    HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES
    K Number
    K925363
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Perusahaan Intan Emas Sdn. Bhd.
    Date Received
    October 22, 1992
    Decision Date
    July 6, 1993
    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 Perusahaan Intan Emas Sdn. Bhd.

    K Number Device Name
    K982691 MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
    K935033 MULTI-COMFORT POWDER FREE
    K892074 PATIENT EXAMINATION GLOVES (LATEX)