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510(k) Data Aggregation
(149 days)
The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
The medical face mask is designed and manufactured by Jiangsu Province Jianerkang Medical Dressing Co., Ltd. It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire. It is a self-inhalation filter mask, which works by filtering the air containing microorganisms, body fluids, and particulate matters through the filter material of the mask before being inhaled or exhaled. The product is level 1 according to ASTM F2100-19.
The document describes the acceptance criteria and performance data for a Medical Face Mask (K202061).
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (ASTM F2100-19 Level 1 unless otherwise specified) | Reported Device Performance |
|---|---|---|
| Flammability | Class 1 | Class 1 (Pass) |
| Bacterial Filtration Efficiency (BFE) | ≥95% (as per device description, Level 1) | Average 99.8% (Reported as Level 3 performance) |
| Differential Pressure (Delta P) |
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