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

    LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    K Number: K001274 · Decision Jun 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    11
    Review Days
    64

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    Basic Information

    Device Name
    LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K Number
    K001274
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pt. Maja Agung Latexindo
    Date Received
    April 20, 2000
    Decision Date
    June 23, 2000
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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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
    K020040 LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
    K013996 LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE
    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 →