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510(k) Data Aggregation

    K Number
    K210524
    Device Name
    Surgical Mask
    Manufacturer
    Changzhou Holymed Products Co., Ltd.
    Date Cleared
    2021-07-07

    (134 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K160269
    Predicate For
    N/A
    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 transfer of microorganisms, body fluids and particulate material. The surgical mask is 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 surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges.

    The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex.

    A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose.

    The surgical mask is intended to be a single-use disposable device, provided non-sterile.

    AI/ML Overview

    The provided text is a 510(k) Summary for a Surgical Mask, specifically K210524 from Changzhou Holymed Products Co., Ltd. It details the device, its intended use, comparison to a predicate device, and performance testing to demonstrate substantial equivalence.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The core of the performance testing is summarized in Table 2: Non-Clinical Performance Testing Table on page 6.

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    Fluid Resistance (ASTM F1862)Determine the ability of the mask's material to resist penetration of blood and body fluids.Pass/fail basis at any of three velocities corresponding to the range of human blood pressure:
    Level 1 – 80 mmHg
    Level 2 – 120 mmHg
    Level 3 - 160 mmHgLevel 3
    Passed at 160 mmHg.
    All 3 lots tested passed with no synthetic blood penetration observed at 160 mmHg, under the conditions of the test.
    Particulate Filtration Efficiency (ASTM F2299)Determine the ability of the mask's material to prevent passage of aerosolized submicron particulates.Pass/fail basis:
    Level 1 – 95%
    Level 2 – 98%
    Level 3 – 98%Level 3
    Passed at > 99.9%
    Average Filtration Efficiency:
    AMSB-LOT202010007: >99.979%
    AMSB-LOT202011002: >99.9814%
    AMSB-LOT202011005: >99.984%
    Bacterial Filtration Efficiency (ASTM F2101-19)Determine the ability of the mask's material to prevent passage of aerosolized bacteria.Pass/fail basis:
    Level 1 - 95%
    Level 2 – 98%
    Level 3 – 98%Level 3
    Passed at ≥ 99.9%
    All samples tested passed with a filtration efficiency percentage of at least 99.9%, under the conditions of the test.
    Differential Pressure (ASTM F2101-19, same as BFE)Determine the resistance of the surgical facemask to air flowing through the mask.Pass/fail basis:
    Level 1 –
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