BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇴 British Indian Ocean Territory

    PATIENT EXAMINATION GLOVEWS

    K Number: K913531 · Decision Jan 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    152

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOVEWS
    K Number
    K913531
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pt. Sarana Indoprotex
    Date Received
    August 8, 1991
    Decision Date
    January 7, 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 Pt. Sarana Indoprotex

    K Number Device Name
    K980605 LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
    K970773 POWDER-FREE EXAM GLOVES
    K950823 ANDAL