BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX)

    K Number: K890967 · Decision May 4, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    5
    Review Days
    66

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    Basic Information

    Device Name
    VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX)
    K Number
    K890967
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Amerimed US Corp.
    Date Received
    February 27, 1989
    Decision Date
    May 4, 1989
    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 Amerimed US Corp.

    K Number Device Name
    K891722 LATEX EXAM GLOVES (MFG. SHANGHAI MEHECO)
    K891437 PATIENT EXAMINATION GLOVES (LATEX)
    K891436 PATIENT EXAMINATION GLOVES (LATEX)
    K883522 AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT