(169 days)
The Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The Medical Face Masks are single use, disposable device, provided non-sterile.
The Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer (meltblown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nose piece (iron wire with white plastic covering) to provide a firm fit over the nose.
The provided text describes the acceptance criteria and performance data for a Medical Face Mask, not an AI-powered diagnostic device. Therefore, the questions related to AI device performance metrics, such as human reader improvement with AI assistance, standalone algorithm performance, AI training/test set details, and expert adjudication, are not applicable to this document.
However, I can extract the information relevant to the medical device's performance as described in the provided text.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristics | Acceptance Criteria | Test Result |
|---|---|---|
| Bacterial Filtration Efficiency Performance (%) | ≥98 | 99.9% |
| Differential Pressure (Delta-P) (mm H2O/cm²) |
§ 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.