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

    Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves

    K Number: K171279 · Decision Oct 12, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    17
    Review Days
    164

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    Basic Information

    Device Name
    Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
    K Number
    K171279
    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
    Top Glove Sdn. Bhd.
    Date Received
    May 1, 2017
    Decision Date
    October 12, 2017
    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 Top Glove Sdn. Bhd.

    K Number Device Name
    K192111 Biodegradable Nitrile Examination Powder Free Glove, Green
    K193150 Latex Examination Powder Free Glove, Aloe Vera
    K172923 Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
    K122999 POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K023974 ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES
    K021855 TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
    K993664 SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
    K993605 PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
    K993452 GREEN POWDERED LATEX EXAMINATION GLOVES
    K993680 SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
    Search all 17 clearances from Top Glove Sdn. Bhd. →