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510(k) Data Aggregation

    K Number
    K201137
    Device Name
    Asept Surgical Face Mask
    Manufacturer
    PFM Medical, Inc
    Date Cleared
    2020-08-19

    (113 days)

    Product Code
    FXX,REG
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K111559
    Why did this record match?
    Device Name :

    Asept Surgical Face Mask

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

    The ASEPT® Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

    Device Description

    ASEPT® Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. The ASEPT® Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device.

    AI/ML Overview

    The document describes the acceptance criteria and performance of the ASEPT® Surgical Face Mask.

    1. A table of acceptance criteria and the reported device performance

    ItemStandardAcceptance CriteriaReported Device Performance
    Fluid Resistance PerformanceASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic BloodAt least 29 out of 32 specimens show passing results at 120 mmHgAll samples met the predetermined acceptance criteria.
    Bacterial Filtration EfficiencyASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks≥ 98%All samples met the predetermined acceptance criteria.
    Differential Pressure (Delta P)ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks
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