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

    BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)

    K Number: K992020 · Decision Jul 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    40

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    Basic Information

    Device Name
    BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
    K Number
    K992020
    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
    Brightsway Holdings Sdn Bhd
    Date Received
    June 16, 1999
    Decision Date
    July 26, 1999
    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 Brightsway Holdings Sdn Bhd

    K Number Device Name
    K992021 BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)
    K991750 BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN
    K991752 BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE