(83 days)
Meets the CDC guidelines for TB exposure control. Has a filter efficiency level of 95% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.
Respirator consisting of nonwoven inter facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic clastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.
This document is a 510(k) Premarket Notification for a respirator and surgical mask. It primarily focuses on demonstrating equivalence to a predicate device through performance testing. Therefore, it does not involve the type of study design or criteria typically used for AI-driven medical devices, which the provided questions are geared towards.
Here's an analysis based on the information provided, highlighting why many questions are not directly applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Filtration Efficiency ≥ 95% for 0.3 micron particles (NIOSH standard) | Met NIOSH required sodium chloride test; no filtration efficiency drop below 95%. |
| No fluid penetration with 2cc synthetic blood at arterial speed | No fluid penetration observed. |
| Qualitative Face Fit test passed | Samples tested successfully. |
| Initial inhalation resistance |
§ 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.