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

    NITRILE EXAMINATION GLOVES (POWERED)

    K Number: K003922 · Decision Feb 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    12
    Review Days
    57

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    Basic Information

    Device Name
    NITRILE EXAMINATION GLOVES (POWERED)
    K Number
    K003922
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Guthrie Medicare Products (Melaka) Sdn Bhd
    Date Received
    December 20, 2000
    Decision Date
    February 15, 2001
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by Guthrie Medicare Products (Melaka) Sdn Bhd

    K Number Device Name
    K003985 POWDERFREE NITRILE PATIENT EXMINATION GLOVE
    K010078 GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
    K010054 GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
    K003872 GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
    K001049 GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)
    K001047 GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
    K000090 GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
    K993793 GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
    K990228 GUTHRIE PRIME POWDER-FREE
    K954967 GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES
    Search all 12 clearances from Guthrie Medicare Products (Melaka) Sdn Bhd →