(96 days)
This single-use surgical mask EFXPLY3SMSK is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure of blood and body fluids. This is a single use, disposable device, non-sterile.
The device is a flat pleated type mask the outer layer being blue and the inner layer being white, utilizing ear loops to secure the mask in place, and a nose bridge is also incorporated for a proper fit around the nose. The device number is EFX3PLYSMSK.
The device is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, and the middle layer is made of melt-blown polypropylene filter material. The model EFX3PLYSMSK device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polypropylene and spandex. The nose bridge contained within the device is placed between the layers of the surgical mask to allow the user to fit the surgical mask properly around their nose. The nose bridge is made up of galvanized with polyethylene.
Here's a breakdown of the acceptance criteria and study information for the Disposable Surgical Face Mask, based on the provided document:
Acceptance Criteria and Device Performance
Level 3 Performance
| Test Methodology | Accepted Criteria (Level 3) | Reported Device Performance (EFX3PLYSMSK) | Result |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | 160mm Hg. | 95 of 96 samples passed | Pass |
| Particulate Filtration Efficiency ASTM F2299 | ≥98% | 99.79% Filtration average efficiency across 96 samples | Pass |
| Bacterial Filtration Efficiency ASTM F2101-19 | ≥98% | 99.8% Filtration average efficiency across 96 samples | Pass |
| Differential Pressure (Delta P) AMST F2100-19 |
§ 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.