(235 days)
Single-use medical face mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
The proposed device is single-use medical face mask. It is non-sterile and for single use. The single-use medical face mask is manufactured with three-layers, the inner and outer layers are made of spun-bond polyethylene, and the middle layer is made of melt blown Polyethylene. The elastic ear loop of proposed device is made of spandex and polyester, not natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from zinc strip. It is a self-inhalation filter mask, which works by filtering the air through the filter material of the mask before being inhaled or exhaled.
This document is a 510(k) summary for a Single-use medical face mask. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Methods | Reported Device Performance | Acceptance Criteria |
|---|---|---|---|
| Resistance to Penetration by synthetic blood (mmHg) | ASTM F2100-19 / ASTM F1862/ASTM F1862-2017 | 80 | Level 1: 80 |
| Sub-Micron Particulate Filtration Efficiency (PFE) at 0.1 micron (%) | ASTM F2100-19 / ASTM F2299 / ASTM F2299-2003(2017) | Average 99.8% | Level 1: ≥95% |
| Bacterial Filtration Efficiency Test (BFE), % | ASTM F2100-19 / ASTM F2101-19 | Average 99.9% | Level 1: ≥95% |
| Flammability | ASTM F2100-19 / 16 CFR Part 1610-2019 | NA (result implicit Class 1) | Class 1 |
| Differential Pressure Test mm H₂O/cm² | ASTM F2100-19 / EN 14683:2019+AC:2019(E) Annex C | Average 2.44 | Level 1: |
§ 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.