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510(k) Data Aggregation

    K Number
    K201514
    Device Name
    Child Face Mask
    Manufacturer
    Shandong Shengquan New Material Co., Ltd.
    Date Cleared
    2021-10-10

    (489 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Child Face Mask

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

    Children Face Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatric patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision.

    Device Description

    Children Face Mask is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials.

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding a Child Face Mask. It does not contain information about an AI/ML medical device, clinical study, acceptance criteria, or ground truth establishment.

    Therefore, I cannot answer your request based on the provided text. The document is about a physical medical device (face mask) and its regulatory clearance, not about the performance or validation of an AI system.

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