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

    LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS

    K Number: K011749 · Decision Aug 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
    K Number
    K011749
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sempermed USA, Inc.
    Date Received
    May 31, 2001
    Decision Date
    August 22, 2001
    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 Sempermed USA, Inc.

    K Number Device Name
    K011407 LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO