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

    POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1

    K Number: K101103 · Decision Jul 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    87

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    Basic Information

    Device Name
    POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1
    K Number
    K101103
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Best Putra Gloves Sdn Bhd
    Date Received
    April 20, 2010
    Decision Date
    July 16, 2010
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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    Other Clearances by Best Putra Gloves Sdn Bhd

    K Number Device Name
    K101105 POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1
    K101106 POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
    K101102 POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE