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

    BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN

    K Number: K991750 · Decision Jun 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN
    K Number
    K991750
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Brightsway Holdings Sdn Bhd
    Date Received
    May 24, 1999
    Decision Date
    June 23, 1999
    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 Brightsway Holdings Sdn Bhd

    K Number Device Name
    K992020 BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
    K992021 BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)
    K991752 BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE