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

    AAMI3 Isolation Gown

    K Number: K213832 · Decision May 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    4
    Review Days
    158

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    Basic Information

    Device Name
    AAMI3 Isolation Gown
    K Number
    K213832
    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
    Hubei Xinxin Non-Woven Co., Ltd.
    Date Received
    December 9, 2021
    Decision Date
    May 16, 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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    Other Clearances by Hubei Xinxin Non-Woven Co., Ltd.

    K Number Device Name
    K253003 Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
    K214116 AAMI4 Isolation Gown
    K212120 Surgical Masks