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510(k) Data Aggregation
(88 days)
Disposable Medical Face Mask (ear loop)
The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of Galvanized iron wire coated by PE, and the ear loop is made of polyester and spandex.
The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask. It focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device (K210433) by providing non-clinical test data.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|
| Fluid Resistance: 29 out of 32 pass at 160 mmHg | Pass: 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency: $\ge$ 98% | Pass: Average 99.36% |
| Bacterial Filtration Efficiency: $\ge$ 98% | Pass: Average 99.40% |
| Differential Pressure (Delta P): |
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