(124 days)
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.