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

    Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

    K Number: K231643 · Decision Sep 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    17
    Review Days
    95

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    Basic Information

    Device Name
    Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
    K Number
    K231643
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntex Healthcare Products Co., Ltd.
    Date Received
    June 5, 2023
    Decision Date
    September 8, 2023
    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 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
    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
    K022090 SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
    Search all 17 clearances from Syntex Healthcare Products Co., Ltd. →