BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DASH, VITAL GARD

    K Number: K974114 · Decision Dec 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    3
    Review Days
    48

    Basic Information

    Device Name
    DASH, VITAL GARD
    K Number
    K974114
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DASH MEDICAL GLOVES SDN BHD
    Date Received
    October 31, 1997
    Decision Date
    December 18, 1997
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by DASH MEDICAL GLOVES SDN BHD

    K Number Device Name
    K992128 DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
    K955425 DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM