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

    Disposable Latex Powder Free Examination Gloves (Non-sterile)

    K Number: K201576 · Decision May 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    3
    Review Days
    342

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    Basic Information

    Device Name
    Disposable Latex Powder Free Examination Gloves (Non-sterile)
    K Number
    K201576
    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. Universal Gloves
    Date Received
    June 11, 2020
    Decision Date
    May 19, 2021
    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. Universal Gloves

    K Number Device Name
    K211360 Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
    K203074 Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)