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

    Thermoplastic Elastomer (TPE) Hybrid Examination Glove

    K Number: K210463 · Decision Jan 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    341

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    Basic Information

    Device Name
    Thermoplastic Elastomer (TPE) Hybrid Examination Glove
    K Number
    K210463
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xuzhou Full Sun Medical Products , Ltd.
    Date Received
    February 16, 2021
    Decision Date
    January 23, 2022
    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 Xuzhou Full Sun Medical Products , Ltd.

    K Number Device Name
    K111240 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
    K072377 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR
    K071122 DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR
    K072314 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
    K072472 DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
    K072401 DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
    K071123 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR