BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Plus Medical Isolation Gown Level 3

    K Number: K212698 · Decision Mar 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    8
    Review Days
    189

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    Basic Information

    Device Name
    Plus Medical Isolation Gown Level 3
    K Number
    K212698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Foshan Nanhai Plus Medical Co, Ltd.
    Date Received
    August 25, 2021
    Decision Date
    March 2, 2022
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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