LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K220749
    Device Name
    Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
    Manufacturer
    Unimax Medical Products Co., Ltd.
    Date Cleared
    2022-05-13

    (60 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203426
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surgical Face Mask is 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 a single use, disposable device(s), provided non-sterile.

    Device Description

    Surgical Face Mask is composed of Nylon and Spandex ear loops, Iron-plastic nose clip, Inner layer Spunbond polypropylene, Middle Melt-blown polypropylene and outer Spun-bond polypropylene. The meltblown polypropylene material acts as the filter that stops microbes from entering or exiting the mask. Surgical Face Masks feature pleats or folds. Three pleats are used to allow the user to expand the mask such that it covers the area from the nose to the chin. The type is ear-loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

    AI/ML Overview

    The provided document describes the non-clinical testing performed for a Surgical Face Mask (Model: 17.5X9.5CM EAR-LOOP) to demonstrate its substantial equivalence to a legally marketed predicate device. This is not an AI/ML medical device, and therefore, the requested information regarding AI/ML-specific study aspects (like expert ground truth establishment, MRMC studies, training/test set details, etc.) is not applicable to this document.

    The document focuses on the physical performance and biocompatibility of the surgical face mask, comparing it to established industry standards for surgical apparel.

    Here's the relevant information extracted and presented based on the document:

    Device: Surgical Face Mask, Model: 17.5X9.5CM EAR-LOOP
    Regulatory Class: Class II
    Product Code: FXX
    Regulation Number: 21 CFR 878.4040 (Surgical Apparel)
    Predicate Device: K203426, Surgical Face Mask (non-sterile)

    Study Type: Non-clinical (performance and biocompatibility)
    Clinical Test Conclusion: No clinical study was included in this submission.

    1. Table of Acceptance Criteria and Reported Device Performance

    The device is evaluated against ASTM F2100-19 Level 2 performance standards and ISO 10993 for biocompatibility.

    ItemPurposeAcceptance Criteria (ASTM F2100-19 Level 2)Reported Device Performance (Result; average performance if provided)
    Fluid Resistance (ASTM F1862)Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure29 out of 32 pass at 120 mmHgPASS (Results for individual lots not detailed beyond "PASS" matching the criteria)
    Particulate Filtration Efficiency (ASTM F2299)Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron≥ 98%PASS (Lot1: 99.17%, Lot2: 99.49%, Lot3: 98.90%)
    Bacterial Filtration Efficiency (ASTM F2101)Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism≥ 98%PASS (Lot1: 99.87%, Lot2: 99.9%, Lot3: 99.84%)
    Differential Pressure (Delta P) (EN 14683 Annex C)Assess the performance of a mask for resistance to air movement through the materials of the face of the mask
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1