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

    POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1

    K Number: K101105 · Decision Nov 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    204

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    Basic Information

    Device Name
    POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1
    K Number
    K101105
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Best Putra Gloves Sdn Bhd
    Date Received
    April 20, 2010
    Decision Date
    November 10, 2010
    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 Best Putra Gloves Sdn Bhd

    K Number Device Name
    K101106 POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
    K101102 POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE
    K101103 POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1