BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ComfortGuard Surgical Isolation Gown

    K Number: K210131 · Decision Aug 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    4
    Review Days
    219

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    Basic Information

    Device Name
    ComfortGuard Surgical Isolation Gown
    K Number
    K210131
    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
    Gri-Alleset, Inc.
    Date Received
    January 19, 2021
    Decision Date
    August 26, 2021
    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 Gri-Alleset, Inc.

    K Number Device Name
    K242664 gentleheel® Adult Incision Device
    K220917 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
    K210860 Comfort Guard Mask, level 1, Comfort Guard Mask, level 3