(127 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.
This document describes the premarket notification (510(k)) for the BASE4 Disposable Medical Mask, outlining its acceptance criteria and the studies performed to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Reported Device Performance | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 31 out of 32 pass at 80 mm Hg; 30 out of 32 pass at 120 mm Hg | 29 out of 32 pass at 120 mm Hg | Pass (Level 2) |
| Particulate Filtration Efficiency (ASTM F2299) | 98.8% | ≥ 98% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | > 99.9% | ≥ 98% | Pass |
| Differential Pressure (Delta P) MIL-M-36954C | 4.4 mmH2O/cm² |
§ 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.