(144 days)
This product meets CDC guidelines for M. tuberculosis exposure control. As a This product incels ODO galdemiseace wearer exposure to certain airborne particles including those generated by electrocautery, laser surgery, and other powered medical instruments. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials.
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This document (a 510(k) clearance letter) describes the clearance of a 3M N95 Health Care Particulate Respirator and Surgical Mask. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the detailed information necessary to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: This letter only states that the device "meets CDC guidelines for M. tuberculosis exposure control" and is "fluid resistant to splash and spatter of blood and other infectious materials." It does not provide a table with specific numerical acceptance criteria (e.g., filtration efficiency percentage, fluid resistance mmHg) or the corresponding reported device performance values.
- Study Design Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Data): The letter does not describe any specific study's methodology, results, or ground truth establishment. It refers to the 510(k) premarket notification (K063023), which would contain the detailed technical data and performance studies. The letter is the outcome of the FDA's review of that submission, not the submission itself.
To answer your questions fully, one would need to access the full 510(k) submission for K063023, which is typically a much more extensive document.
Therefore, I cannot provide the requested table and detailed study information based solely on the provided text.
§ 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.