(138 days)
The Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device. This product contains no components made from natural rubber latex.
This document is a 510(k) premarket notification for a medical device: a Disposable Medical Mask (K212826). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a set of acceptance criteria through a clinical study that uses AI or human readers for diagnosis. Therefore, several aspects of your request (related to AI, human readers, ground truth establishment for a training set, the number of experts, and adjudication methods for a test set) are not applicable to the content provided.
However, I can extract the acceptance criteria and performance data for the physical properties and biocompatibility of the medical mask, as these are the "device performance" aspects evaluated in this submission for regulatory clearance.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document presents performance criteria for the Disposable Medical Mask based on established ASTM and EN standards for medical face masks.
| Test / Performance Metric | Standard(s) | Acceptance Criteria (for Level 2 Mask) | Reported Device Performance | Pass/Fail |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE, %) | ASTM F2101 | ≥ 98% | Average 99.79% | Pass |
| Particulate Filtration Efficiency (PFE, at 0.1µm, %) | ASTM F2299 | ≥ 98% | Average 99.13% | Pass |
| Differential Pressure (Delta P, mm H2O/cm²) | ASTM F2100-19, EN 14683:2019, Annex C |
§ 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.