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510(k) Data Aggregation
(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) |
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