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510(k) Data Aggregation

    K Number
    K210304
    Device Name
    Surgical Mask
    Manufacturer
    Jin Pin Electrical CO., LTD. Zhuhai S.E.Z.
    Date Cleared
    2021-05-04

    (90 days)

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

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

    Device Description

    Surgical Mask (Model KZ-D31)

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a Surgical Mask (Model KZ-D31). It does not contain information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. The document explicitly states that it is for a "Surgical Mask (Model KZ-D31)" which is a physical device, not a software or AI-based product.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML based device from this text.

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