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

    MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)

    K Number: K010438 · Decision May 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    26
    Review Days
    77

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    Basic Information

    Device Name
    MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)
    K Number
    K010438
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terang Nusa Sdn Bhd
    Date Received
    February 13, 2001
    Decision Date
    May 1, 2001
    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 Terang Nusa Sdn Bhd

    K Number Device Name
    K170779 Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
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    K153510 Powder Free Polychloroprene Examination Glove Green
    K151392 Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
    K140355 SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
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    K102230 NUGARD NITILE GREY COLOR
    K102119 SUR-G GLOV AND MAXITEX
    K083337 NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
    K052837 SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
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