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

    LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM

    K Number: K020040 · Decision Aug 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    11
    Review Days
    206

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    Basic Information

    Device Name
    LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
    K Number
    K020040
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pt. Maja Agung Latexindo
    Date Received
    January 7, 2002
    Decision Date
    August 1, 2002
    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 Pt. Maja Agung Latexindo

    K Number Device Name
    K212408 Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
    K161099 Powder Free Nitrile Examination Gloves, Black
    K081488 POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
    K062709 POWDER FREE LATEX EXAMINATION GLOVES, BLACK
    K013996 LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE
    K001274 LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K994255 LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
    K992752 SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5
    K982897 POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K896604 MAL LATEX EXAMINATION GLOVES
    Search all 11 clearances from Pt. Maja Agung Latexindo →