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510(k) Data Aggregation

    K Number
    K142764
    Device Name
    KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
    Manufacturer
    HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD.
    Date Cleared
    2015-07-09

    (287 days)

    Product Code
    CBP,III
    Regulation Number
    868.5870
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K081516,K112126
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD.

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

    The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is for prescription use.

    The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring cardiopulmonary resuscitation (CPR) resuscitator without oxygen port is for overthe-counter use.

    Device Description

    The KYOLING CPR mask is used during cardiopulmonary resuscitation procedures, which are used in emergency situations to supply oxygen and produce blood flow in the heart and lungs.

    The CPR mask is made of PVC and one-way valve made of medical grade K-resin, the mask is used for mouth-to-mask breathing, it provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with the unknown subject; and also it promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. The KYOLING CPR Mask includes transparent dome, universal breathing tube, one-way filtered valve, head strap, and with Oxygen Port or without Oxygen Port.

    AI/ML Overview

    The provided document describes the acceptance criteria and a study to prove that the KYOLING CPR mask with and without an oxygen port meets these criteria.

    Here's a breakdown of the requested information:

    1. A table of acceptance criteria and the reported device performance

    ParameterAcceptance CriteriaReported Device Performance (KYOLING CPR Mask with Oxygen Port)Reported Device Performance (KYOLING CPR Mask without Oxygen Port)
    BiocompatibilityMeeting ISO 10993 standards for cytotoxicity, sensitization, and irritationAll tests conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1, with tests for cytotoxicity, sensitization, and irritation completed. Cushion and valve considered surface contacting for
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