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

    POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES

    K Number: K945767 · Decision Mar 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    30
    Review Days
    101

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    Basic Information

    Device Name
    POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES
    K Number
    K945767
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ansell, Inc.
    Date Received
    November 21, 1994
    Decision Date
    March 2, 1995
    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 Ansell, Inc.

    K Number Device Name
    K984392 ANSELL CONDOMS
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    K953379 HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE
    K945766 HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES
    K940045 CONDOM
    K940046 NON-LUBRICATED CONDOM
    K913766 ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
    K914760 LATEX EXAMINATION GLOVES
    K903107 PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)
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