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Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile.

Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile.

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The provided document is a 510(k) clearance letter for Cardinal Health Surgical Masks. This type of document does not contain the detailed technical study information requested in your prompt.

510(k) clearances are primarily concerned with demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through novel studies in the way an AI/ML device would. The FDA typically relies on existing standards (e.g., ASTM standards for medical masks) for performance evaluation in these cases.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report for an AI/ML device.

Therefore, I cannot provide the requested information based on the provided text.

If this were an AI/ML device, the information would typically be found in sections detailing performance data, clinical validation, or technical specifications.

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