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

    PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE)

    K Number: K962650 · Decision Aug 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    38

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    Basic Information

    Device Name
    PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE)
    K Number
    K962650
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sti Medical Sdn Bhd
    Date Received
    July 8, 1996
    Decision Date
    August 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 Sti Medical Sdn Bhd

    K Number Device Name
    K970613 PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)