(113 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The Nordiwell Medical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made from Natural Rubber Latex. Shelf-life of the device is 2 years.
The provided text describes the acceptance criteria and the study conducted for the Nordiwell Medical Face Mask (K202615) to demonstrate substantial equivalence to a predicate device. This is a medical device, specifically a surgical face mask, not an AI/ML powered device. Therefore, many of the requested categories in the prompt, such as those related to AI model performance, expert ground truth, adjudication methods, and training/test sets for AI, are not applicable.
Here's the information that can be extracted from the provided text, focused on the device's physical and performance characteristics:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Nordiwell Medical Face Mask (K202615)
| Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-17) | ≥29 of 32 pass at 160 mmHg | 32 of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥ 98% | > 99.9% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥ 98% | > 99.9% | Pass |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM 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.