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510(k) Data Aggregation
(92 days)
Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. This is a single use device, provided non-sterile.
Medical Surgical Mask is a non-sterile, single use, three-layer mask with earloops and nose piece. The Medical Surgical Mask is manufactured with three layers, the outer and inner layers are made of non-woven fabric, and the middle layer is made of melt-blown fabric. The earloops are made of polyester textured yarn. The nose piece is made of polyethylene, which allow the users to adjust the nose piece according to the shape of the bridge of the nose.
The provided text describes the acceptance criteria and the study results for a medical surgical mask (Model: ZKM-U01). It does not pertain to an AI/ML powered device, therefore, information such as human-in-the-loop performance, effect size of AI assistance, and details about training/test set provenance are not applicable.
Here's a summary of the available information:
1. Acceptance Criteria and Reported Device Performance:
| Test Methodology | Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | No penetration pass at 120mmHg | Pass, no penetration pass at 120mmHg | Yes |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥98% | Pass, average 99.99% | Yes |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥98% | Pass, average > 99.8% | Yes |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) |
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