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

    POWDER-FREE PATIENT EXAMINATION GLOVES

    K Number: K931406 · Decision Oct 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    7
    Review Days
    216

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    Basic Information

    Device Name
    POWDER-FREE PATIENT EXAMINATION GLOVES
    K Number
    K931406
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    P.T. Healthcare Glovindo
    Date Received
    March 19, 1993
    Decision Date
    October 21, 1993
    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 P.T. Healthcare Glovindo

    K Number Device Name
    K021659 PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)
    K010232 PRE-POWDERED NITRILE EXAMINATION GLOVES
    K010233 POWDER FREE NITRILE EXAMINATION GLOVES
    K000838 DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K974853 LATEX (POWDER FREE) LOW PROTEIN
    K930995 POWDERED EXAMINATION GLOVES