(218 days)
The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This face mask is 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 as sterile.
The surgical face mask is provided as sterile, single use, 3 lavers, flat-pleated style with ear loops and nose-piece. The outer layer and inner layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt-blown fabric (polypropylene). Each mask contains ear loops to secure the mask over the user's face and mouth with nose-piece to firmly fit over the nose. This device is not made from any natural rubber latex.
The provided text describes the acceptance criteria and the study proving the device meets these criteria for a Surgical Face Mask. It is important to note that this is a medical device, not an AI/Software as a Medical Device (SaMD), so the questions related to AI performance, such as MRMC studies, training sets, and expert adjudication, are not applicable in this context. The document focuses on physical, biological, and sterilization performance of the mask.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data are primarily found in section 7.2 Physical performance testing and the Biocompatibility section within the comparison table.
| Performance Test | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F 1862-17) @ 120 mmHg | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg (Statistics of three lots) | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥ 98% | 99.6%-99.8% (Statistics of three lots) | Pass |
| Differential Pressure (Delta-P) (EN 14683: 2019) |
§ 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.