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

    BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)

    K Number: K991940 · Decision Jul 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    24
    Review Days
    33

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    Basic Information

    Device Name
    BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)
    K Number
    K991940
    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
    Brightway Holdings Sdn. Bhd.
    Date Received
    June 9, 1999
    Decision Date
    July 12, 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 Brightway Holdings Sdn. Bhd.

    K Number Device Name
    K211816 Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K170686 Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
    K162294 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K162186 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
    K163267 NITRILE EXAMINATION GLOVE
    K162146 Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
    K161215 Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs
    K102880 BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)
    K060402 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
    K060658 BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
    Search all 24 clearances from Brightway Holdings Sdn. Bhd. →