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

    DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS

    K Number: K992128 · Decision Sep 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    3
    Review Days
    83

    Basic Information

    Device Name
    DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
    K Number
    K992128
    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
    June 23, 1999
    Decision Date
    September 14, 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 DASH MEDICAL GLOVES SDN BHD

    K Number Device Name
    K974114 DASH, VITAL GARD
    K955425 DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM