(90 days)
The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose. The product is level 1 according to ASTM F2100-19.
This document describes the premarket notification (510(k)) for a Medical Face Mask, focusing on its substantial equivalence to a legally marketed predicate device. The information provided is for a physical medical device (a face mask) and not an AI/ML-driven device. Therefore, many of the requested details about AI model performance, training sets, ground truth establishment by experts, adjudication, and MRMC studies are not applicable to this document.
However, I can extract and present the acceptance criteria and the study results for this specific medical device.
Device: Medical Face Mask (K212471)
Predicate Device: Surgical Face Masks (Ear loops and Tie-on) (K160269)
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are "Pass" for all tests, with specific quantitative thresholds where applicable. The reported device performance is that all tests met these criteria.
| Item | Test Methods | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Flammability | ASTM F2100-19, 16 CFR Part 1610-2008 | Class 1 | Pass |
| Bacterial Filtration Efficiency (BFE) | ASTM F2100-2019 9.1, ASTM F2101-2019 | ≥95% | Pass |
| Differential Pressure | ASTM F2100-19 9.2 |
§ 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.