(307 days)
Allmed Surgical Face Masks(Ear Loops) are intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The surgical face mask is a single use, disposable device provided non-sterile.
Allmed surgical face masks (ear loops) are composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene meltblown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical face mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.
The document describes the acceptance criteria and performance of the Allmed Surgical Face Masks (Ear Loops) as per their 510(k) summary. This is not a study of an AI-powered device, but rather a regulatory submission for a medical device (surgical face mask). Therefore, information related to AI-specific studies, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth, or training set details, is not applicable or present in this document.
Here's the information available:
1. Table of acceptance criteria and the reported device performance:
| Test Method (Test Identification) | Purpose (summarized) | Acceptance Criterion (ASTM F2100 Level 3) | Test Result |
|---|---|---|---|
| ASTM F2101-Bacterial Filtration Efficiency (BFE) | Compare bacterial control counts upstream and downstream to determine filtration efficiency. | ≥98%, AQL=4% | Passed |
| ASTM F2299-Particulate Filtration Efficiency (PFE) | Evaluate non-viable particle filtration efficiency. | ≥98%, AQL=4% | Passed |
| EN14683:2019 Annex C-Differential Pressure | Determine breathability by measuring differential air pressure. |
§ 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.