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

    POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES

    K Number: K003904 · Decision Jan 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    7
    Review Days
    36

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    Basic Information

    Device Name
    POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
    K Number
    K003904
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Purna Bina Sdn Bhd
    Date Received
    December 19, 2000
    Decision Date
    January 24, 2001
    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 Purna Bina Sdn Bhd

    K Number Device Name
    K130450 SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE
    K083571 ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
    K041004 ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
    K022659 ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
    K994420 POWDER FREE LATEX EXAMINATION PATIENT GLOVES
    K891507 PATIENT EXAMINATION GLOVES (LATEX)