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510(k) Data Aggregation

    K Number
    K210513
    Device Name
    UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2
    Manufacturer
    Universal Incorporation
    Date Cleared
    2021-09-29

    (218 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K141085
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K141085

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for Adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.

    Device Description

    UNIWEB SURGICAL MASK are 3-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer and middle layer, and is provided with ear loops and nose wire for individualized fit.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study results for the UNIWEB Surgical Mask, a medical device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test MethodologyPurpose of the TestAcceptance Criteria (Level 1)Reported Performance (UNIWEB Surgical Mask - Level 1)Acceptance Criteria (Level 2)Reported Performance (UNIWEB Surgical Mask - Level 2)
    Bacteria Filtration EfficiencyDetermine bacterial filtration efficiency as directed in ASTM F2101≥ 95 %96/96 (3 lots) passed at ≥ 99%≥ 98 %96/96 (3 lots) passed at ≥ 99%
    Particle Filtration EfficiencyDetermine particulate filtration efficiency as directed in ASTM F2299≥ 95 %96/96 (3 lots) passed at ≥ 99%≥ 98 %96/96 (3 lots) passed at ≥ 99%
    Differential Pressure (Delta-P)Determine breathing resistance/differential pressure as directed in EN 14683:2019, Annex C
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