BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

    K Number: K990526 · Decision Apr 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    63

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    Basic Information

    Device Name
    KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
    K Number
    K990526
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ssn Gloves (M) Sdn Bhd
    Date Received
    February 19, 1999
    Decision Date
    April 23, 1999
    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 Ssn Gloves (M) Sdn Bhd

    K Number Device Name
    K012896 STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)
    K012880 STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
    K990527 KLEENHANDS POWDERED LATEX EXAMINATION GLOVES