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510(k) Data Aggregation

    K Number
    K223270
    Device Name
    POSE™ Health Care Surgical Mask
    Manufacturer
    America's Supply Chains
    Date Cleared
    2022-11-01

    (8 days)

    Product Code
    FXX,DEC,POS
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K172500
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The POSE™ Health Care Surgical Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    Device Description

    POSE™ Health Care Surgical Mask is composed of three-layers and is flat fold. The mask materials consist of an outer cover web (polypropylene spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex.

    AI/ML Overview

    The provided document is a 510(k) summary for the POSE™ Health Care Surgical Mask. It outlines the device's technical characteristics, performance data, and comparison to a predicate device to demonstrate substantial equivalence to a legally marketed device.

    Here's a breakdown of the requested information based on the provided text:

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

    ItemAcceptance CriteriaReported Device Performance (POSE™ Health Care Surgical Mask)Result
    Benchtop Performance Testing
    ASTM F1862/ISO 22609 Fluid ResistanceAQL 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: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 passPass
    ASTM F2299 Particulate Filtration Efficiency≥ 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 passPass
    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 passPass
    Differential Pressure ASTM F2100/EN 14683:2019AQL 4%, single sampling plan,
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