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510(k) Data Aggregation

    K Number
    K221753
    Date Cleared
    2023-12-21

    (553 days)

    Product Code
    Regulation Number
    878.4040
    Reference & Predicate Devices
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xinxiang Kangbeier Medical Technology Co., Ltd.

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

    The Kangbeier Child Surgical Mask is intended to be worn by the patient (ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The Kangbeier Child Surgical Mask is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

    Device Description

    The Kangbeier Child Surgical Mask is composed of three layers of materials and pleated to form the mask. The inner layer is composed of spun-bond nonwoven polypropylene, the middle layer is meltblown polypropylene filter material, and the outer layer is spunbond nonwoven polypropylenen. The color on the outer layer is consists of Phthalocyanine Blue and PE wax and PP. Masks are held in place on wearer with elastic spun-bond polypropylene earloop and contain a malleable aluminum nosepiece strip.

    The Kangbeier Child Surgical Mask is appropriately sized to the smaller faces of children across a diverse population.

    The Kangbeier Child Surgical Mask is a single use, disposable device, provided nonsterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Kangbeier Child Surgical Mask. It demonstrates the device's substantial equivalence to a predicate device, K160100, "Prestige Ameritech Pediatric/Child's Face Mask."

    Here's the breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Standard)Predicate Device PerformanceSubject Device PerformanceComparison Summary
    Particulate Filtration Efficiency at 0.1 microns≥98%≥98%Same
    Bacterial Filtration Efficiency (BFE)96.32%≥98%Similar (Subject Device better)
    Differential Pressure (Delta P, mm H2O/cm²)
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    K Number
    K213920
    Date Cleared
    2022-01-16

    (32 days)

    Product Code
    Regulation Number
    878.4040
    Reference & Predicate Devices
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xinxiang Kangbeier Medical Technology Co., Ltd.

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

    The disposable surgical face masks are intended to be worn to protect 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 Kangbeier Surgical Mask (Model: KBR-1001) is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.

    AI/ML Overview

    The document describes the non-clinical testing performed on the Kangbeier Surgical Mask (Model: KBR-1001) to support its 510(k) submission and demonstrate substantial equivalence to a predicate device. This device is a surgical mask, not an AI-based or image analysis device, therefore, many of the requested items related to AI/MRMC studies, ground truth establishment, and data provenance are not applicable.

    Here's an analysis based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document provides a clear table (Table 2) outlining the acceptance criteria and the results for several non-clinical performance tests.

    ItemPurposeAcceptance CriteriaReported Device Performance (Result)
    Level 3 Fluid Resistance Performance ASTM F1862Resistance to Fluid29 Out of 32 pass at 160 mmHgPass
    LOT #1: 30/32 passed, @ 160 mmHg
    LOT #2: 30/32 passed, @ 160 mmHg
    LOT #3: 31/32 passed, @ 160 mmHg
    (Overall: 30-31 Out of 32 pass at 160 mmHg)
    Particulate Filtration Efficiency ASTM F2299Particulate Filtration Efficiency≥ 98%Pass
    LOT #1: AVE Filtration Efficiency ≥ 98%
    LOT #2: AVE Filtration Efficiency ≥ 98%
    LOT #3: AVE Filtration Efficiency ≥ 98%
    (Overall: 98.62-99.34%)
    Bacterial Filtration Efficiency ASTM F2101Bacterial Filtration Efficiency≥ 98%Pass
    LOT #1: AVE Filtration Efficiency ≥ 98%
    LOT #2: AVE Filtration Efficiency ≥ 98%
    LOT #3: AVE Filtration Efficiency ≥ 98%
    (Overall: 99.5 - 99.1%)
    Differential Pressure ASTM F2100Differential Pressure
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