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The above named device is designed to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins.

FACE - 2 - FACE CPR PROTECTION SHIELD

The provided text is an FDA 510(k) clearance letter for the "FACE - 2 - FACE CPR Protection Shield." This document does not contain details about acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

Instead, it's a regulatory letter indicating that the device has been found substantially equivalent to a legally marketed predicate device, thereby allowing it to be marketed. The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act."

The purpose of a 510(k) submission is to demonstrate substantial equivalence, not necessarily to provide detailed performance data against specific acceptance criteria in the manner one might expect for a novel or high-risk device. The "Indications For Use" section merely describes what the device is designed for, and includes a disclaimer that its use does not "gaurantee complete protection from disease transmission."

Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval, not a scientific study report.

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