(287 days)
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.
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.
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
| Parameter | Acceptance Criteria | Reported Device Performance (KYOLING CPR Mask with Oxygen Port) | Reported Device Performance (KYOLING CPR Mask without Oxygen Port) |
|---|---|---|---|
| Biocompatibility | Meeting ISO 10993 standards for cytotoxicity, sensitization, and irritation | All 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 |
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).