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

    SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE

    K Number: K053305 · Decision Jun 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    9
    Review Days
    186

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    Basic Information

    Device Name
    SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
    K Number
    K053305
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pt Mahakarya Inti Buana
    Date Received
    November 28, 2005
    Decision Date
    June 2, 2006
    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 Mahakarya Inti Buana

    K Number Device Name
    K111300 SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
    K090464 BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
    K063581 SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
    K062313 SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
    K061233 SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
    K053366 NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
    K053657 POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
    K052273 POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE