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    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)

    K Number: K980605 · Decision Apr 14, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    56

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    Basic Information

    Device Name
    LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
    K Number
    K980605
    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
    February 17, 1998
    Decision Date
    April 14, 1998
    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
    K970773 POWDER-FREE EXAM GLOVES
    K950823 ANDAL
    K913531 PATIENT EXAMINATION GLOVEWS