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    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE

    K Number: K022088 · Decision Sep 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    17
    Review Days
    68

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    Basic Information

    Device Name
    SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
    K Number
    K022088
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Syntex Healthcare Products Co., Ltd.
    Date Received
    June 27, 2002
    Decision Date
    September 3, 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 Syntex Healthcare Products Co., Ltd.

    K Number Device Name
    K240080 Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K231643 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
    K103770 SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
    K102096 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    K052877 POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
    K042226 SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
    K033777 ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
    K023826 SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
    K022784 SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
    K022092 SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
    Search all 17 clearances from Syntex Healthcare Products Co., Ltd. →