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510(k) Data Aggregation

    K Number
    K213406
    Device Name
    Savvy Mask - Level 3 Surgical Face Mask
    Manufacturer
    Texas MedPlast LLC
    Date Cleared
    2021-11-18

    (30 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K201479
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

    Device Description

    The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are non-sterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains head ties, ear loops or ear bands to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex.

    AI/ML Overview

    This document pertains to the 510(k) summary for the Savvy Mask - Level 3 Surgical Mask. The information provided is primarily focused on the device's technical and performance characteristics compared to a predicate device, rather than the evaluation of an AI or software device.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    ItemAcceptance CriteriaProposed Device - Savvy Mask PerformanceResult
    Level 3 Fluid Resistance (ASTM F1862)AQL 4%, single sampling plan, 29 out of 32 Pass at 160mmHgThree non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. Lot 1: 31/32 pass; Lot 2: 30/32 pass; Lot 3: 31/32 pass.Pass
    Particulate Filtration Efficiency (ASTM F2299)≥ 98%Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass; Lot 2: 32/32 pass; Lot 3: 32/32 pass.Pass
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass; Lot 2: 32/32 pass; Lot 3: 32/32 pass.Pass
    Differential Pressure (ASTM F2100/EN 14683:2019)AQL 4%, single sampling plan, 29/32 pass
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