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

    LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN

    K Number: K991043 · Decision May 4, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    9
    Review Days
    36

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    Basic Information

    Device Name
    LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN
    K Number
    K991043
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Glovco (M) Sdn. Bhd.
    Date Received
    March 29, 1999
    Decision Date
    May 4, 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 Glovco (M) Sdn. Bhd.

    K Number Device Name
    K051345 COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET)
    K042898 PANTHERA N POWDER FREE BLACK NITRILE GLOVES
    K013828 GLOVCO EBONY
    K021730 GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
    K021308 GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
    K994013 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
    K993752 GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K991554 GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)