(204 days)
The surgical mask is 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. This is a single-use, disposable device, provided non-sterile.
The surgical mask is a three-layer, flat pleated facepiece composed of a spunbond outer layer, filter layer, and spunbond (skin-contacting) inner layer. The mask is held in place with an elastic headband, and the position of the mask on the face is maintained with a nose wire and elastic beneath the chin. It is supplied non-sterile and is a single-use disposable.
Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided text.
This document describes the validation of a Surgical Mask, not an AI/software device. Therefore, many of the typical acceptance criteria and study components for AI-driven medical devices (like MRMC studies, ground truth establishment by experts, training/test set provenance, etc.) are not applicable here. The study focuses on physical and biological performance characteristics of the mask according to recognized standards.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established ASTM and ISO standards for surgical masks.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F1862:2017 - Fluid Resistance Performance | Evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. | Class 3 - pass at 160mmHg | |
| Class 2 - pass at 120mmHg | |||
| Class 1- pass at 80mmHg | Pass | ||
| ASTM F2299:2017 - Particulate Filtration Efficiency | Evaluate filtration efficiency by comparing the particle count in the feed stream (upstream) to that in the filtrate (downstream) for the materials used in medical face masks. | >98% | Pass |
| ASTM F2101:2019 - Bacterial Filtration Efficiency | Evaluate the effectiveness of medical face mask materials in preventing the passage of aerosolized bacteria, expressed in the percentage of a known quantity that does not pass the medical face mask material at a given aerosol flow rate. | >98% | Pass |
| EN 14683:2019 - Differential Pressure | Evaluate the resistance to air flow and breathability of a medical face mask by measuring differential pressure through the materials of a mask. |
§ 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.