(34 days)
When properly worn, the Ear-Friendly Masks are intended to protect and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.
The Ear-Friendly Masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. 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.
Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) Summary for the "Ear-Friendly Mask."
Device Description:
The Ear-Friendly Mask is a non-sterile, single-use, 3-layer, flat-pleated surgical face mask with ear loops and a nose piece. It is intended to protect both patients and healthcare workers from the transfer of microorganisms, body fluids, and particulate material.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Ear-Friendly Mask are based on the ASTM F2100 standard for the performance of materials used in surgical face masks, specifically for Level 3 performance. The table below outlines the acceptance criteria and the device's reported performance:
| Test Name | Standard | Acceptance Criteria (ASTM F2100 - Level 3) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|---|
| Fluid Resistance | ASTM F1862 | 160 mmHg | Pass | Yes |
| Particle Filtration Efficiency (PFE) | ASTM F2299 | $\ge$ 98% | Pass | Yes |
| (@ 0.1 micron) | ||||
| Bacterial Filtration Efficiency (BFE) | ASTM F2101 | $\ge$ 98% | Pass | Yes |
| Differential Pressure | MIL-M-36954C |
§ 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.