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

    LATEX EXAM GLOVES (MFG. SHANGHAI MEHECO)

    K Number: K891722 · Decision Jul 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    115

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    Basic Information

    Device Name
    LATEX EXAM GLOVES (MFG. SHANGHAI MEHECO)
    K Number
    K891722
    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
    March 21, 1989
    Decision Date
    July 14, 1989
    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 Amerimed US Corp.

    K Number Device Name
    K891437 PATIENT EXAMINATION GLOVES (LATEX)
    K891436 PATIENT EXAMINATION GLOVES (LATEX)
    K890967 VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX)
    K883522 AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT