BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES

    K Number: K000058 · Decision Mar 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    795
    Applicant Total
    4
    Review Days
    60

    Basic Information

    Device Name
    BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES
    K Number
    K000058
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    KAOHSIUNG BROTHERS PRODUCTS CORP.
    Date Received
    January 10, 2000
    Decision Date
    March 10, 2000
    Product Code
    LYZ
    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
    LYZ Vinyl Patient Examination Glove

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    Other Clearances by KAOHSIUNG BROTHERS PRODUCTS CORP.

    K Number Device Name
    K030200 POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
    K003197 VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW
    K891336 PATIENT EXAMINATION GLOVES (VINYL)