(218 days)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for Adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.
UNIWEB SURGICAL MASK are 3-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer and middle layer, and is provided with ear loops and nose wire for individualized fit.
The provided text describes the acceptance criteria and the study results for the UNIWEB Surgical Mask, a medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose of the Test | Acceptance Criteria (Level 1) | Reported Performance (UNIWEB Surgical Mask - Level 1) | Acceptance Criteria (Level 2) | Reported Performance (UNIWEB Surgical Mask - Level 2) |
|---|---|---|---|---|---|
| Bacteria Filtration Efficiency | Determine bacterial filtration efficiency as directed in ASTM F2101 | ≥ 95 % | 96/96 (3 lots) passed at ≥ 99% | ≥ 98 % | 96/96 (3 lots) passed at ≥ 99% |
| Particle Filtration Efficiency | Determine particulate filtration efficiency as directed in ASTM F2299 | ≥ 95 % | 96/96 (3 lots) passed at ≥ 99% | ≥ 98 % | 96/96 (3 lots) passed at ≥ 99% |
| Differential Pressure (Delta-P) | Determine breathing resistance/differential pressure as directed in 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.