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510(k) Data Aggregation

    K Number
    K252964

    Validate with FDA (Live)

    Device Name
    PRIMED Surgical and Procedure Masks
    Manufacturer
    PRIMED Medical Products Inc.
    Date Cleared
    2025-11-04

    (48 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K240286
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PRIMED Surgical masks are single use, non-sterile, disposable products intended to be worn by healthcare personnel in healthcare settings and during surgical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials.

    PRIMED Procedure Masks are single use, non-sterile, disposable products intended to be worn by healthcare personnel in healthcare settings to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials.

    Device Description

    PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.

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