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

    POWDERED LATEX PATIENT EXAMINATION GLOVES

    K Number: K051913 · Decision Sep 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    77

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    Basic Information

    Device Name
    POWDERED LATEX PATIENT EXAMINATION GLOVES
    K Number
    K051913
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shinemound Enterprise, Inc.
    Date Received
    July 15, 2005
    Decision Date
    September 30, 2005
    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 Shinemound Enterprise, Inc.

    K Number Device Name
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    K994258 SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
    K993240 SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
    K993231 SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
    K971360 SYNTEX
    K972104 LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
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