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510(k) Data Aggregation
(127 days)
Base4 Group, Inc.
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.
This document describes the premarket notification (510(k)) for the BASE4 Disposable Medical Mask, outlining its acceptance criteria and the studies performed to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Reported Device Performance | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 31 out of 32 pass at 80 mm Hg; 30 out of 32 pass at 120 mm Hg | 29 out of 32 pass at 120 mm Hg | Pass (Level 2) |
| Particulate Filtration Efficiency (ASTM F2299) | 98.8% | ≥ 98% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | > 99.9% | ≥ 98% | Pass |
| Differential Pressure (Delta P) MIL-M-36954C | 4.4 mmH2O/cm² |
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