BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    PATIENT EXAMINATION GLOVE

    K Number: K915842 · Decision Apr 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    110

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOVE
    K Number
    K915842
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Precious Mountain Ent. Corp.
    Date Received
    December 26, 1991
    Decision Date
    April 14, 1992
    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 Precious Mountain Ent. Corp.

    K Number Device Name
    K890986 VINYL PATIENT EXAMINATION GLOVE