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510(k) Data Aggregation
(49 days)
The Disposable 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s) , provided non-sterile.
The WellBefore 4 Layers disposable surgical mask is an adult-sized surgical mask equipped with earloops, designed to cower the user's nose and mouth. The surgical face masks are consists of Outer Layer(Non-woven fabric made from spunbond polypropylene), Second Layer(meltblown filtration fabric made from polypropylene), Third Layer(Electrostastic cotton made from ethylene-propylene side by side), Inner Layer(Non-woven fabric made from spunbond polypropylene), Nose Bridge(Double-wirenosepinmade by polypropylene, and Earloops(Polyster Fiber and Spandex). The mask acts as a physical barrier from fuids and particulate materials, and providing a level 3 barrier. It is a single-use, disposable device(s) , provided non-sterile.
Here's a breakdown of the acceptance criteria and study information for the Disposable 4 layers surgical face mask based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Requirement (Acceptance Criteria) | Test Method | Reported Device Performance (Proposed Device) | Outcome |
|---|---|---|---|
| Fluid Resistance: $\ge 29$ out of 32 pass at 160mmHg (level 3) | ASTM F1862 | At least 29 out of 32 passing at 160mmHg | Pass |
| Particulate Filtration Efficiency: $\ge 98%$ | ASTM F2299 | $\ge 98%$ | Pass |
| Bacterial Filtration Efficiency: $\ge 98%$ | ASTM F2101 | $99.9%$ | Pass |
| Differential Pressure (Delta P): $ |
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