(96 days)
The nPro surgical masks are intended for operating room personnel health care workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and particulate materials. nPro Surgical Masks are single use, disposable devices provided non-sterile.
The nPro surgical mask meets ASTM F2100-19 Level 1 performance requirements for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood and flame spread.
The three-ply pleated mask fabric can be vertically adjusted to cover the user's mouth and nose. The inner and outer layers are constructed of non-woven fabric. The middle layer is constructed of melt-blown negative charge non-woven fabric and includes a flexible nose wire to the user's nose and reduce air gaps. The three layers of the mask body are collated and ultrasonically welded around the edges to enclose the filter media and nose wire. The polyester-spandex ear loops are ultrasonically welded to the mask body. All materials are not made with natural rubber latex. The nPro Surgical Masks are single use, disposable devices that are provided non-sterile in a dispensing carton.
This document is a 510(k) premarket notification for a surgical mask, not an AI-powered medical device. Therefore, the information typically requested regarding AI/ML device performance (like MRMC studies, training set details, or multiple expert ground truth establishment) is not applicable here.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted on the surgical mask to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
| Performance Requirements (units) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Bacterial filtration efficiency (%) | ≥95% | Pass, 99.1% |
| Differential pressure (H2O / 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.