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

    MAYTEX NON-STERILE LATEX EXAM GLOVE

    K Number: K892557 · Decision May 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    51

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    Basic Information

    Device Name
    MAYTEX NON-STERILE LATEX EXAM GLOVE
    K Number
    K892557
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Seal Co.
    Date Received
    April 10, 1989
    Decision Date
    May 31, 1989
    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 American Seal Co.

    K Number Device Name
    K972187 BOUFFANT CAP
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    K970814 NON-STERILE ISOLATION GOWN
    K964358 AMSEAL SURGICAL FACE MASK
    K892553 MAYTEX PATIENT EXAMINATION GLOVES