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

    PATIENT EXAMINATION GLOVES (LATEX)

    K Number: K891389 · Decision May 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOVES (LATEX)
    K Number
    K891389
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Rubberex (M) Sdn Berhad
    Date Received
    March 15, 1989
    Decision Date
    May 12, 1989
    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 Rubberex (M) Sdn Berhad

    K Number Device Name
    K893782 PATIENT EXAMINATION GLOVES W/CORN STARCH POWDER