BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

    K Number: K160361 · Decision Nov 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    8
    Review Days
    269

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    Basic Information

    Device Name
    PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
    K Number
    K160361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Primed Medical Products, Inc.
    Date Received
    February 9, 2016
    Decision Date
    November 4, 2016
    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 Primed Medical Products, Inc.

    K Number Device Name
    K252964 PRIMED Surgical and Procedure Masks
    K242208 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    K240286 PRIMED Surgical Masks and PRIMED Procedure Masks
    K233777 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    K213427 PRIMED Pediatric Facemask
    K092012 PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
    K081633 PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS