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510(k) Data Aggregation
(86 days)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical 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 subject Disposable Surgical Face Masks have two model: FM-34EE, Level 2 and Model: FM-44EE, Level 3.
The Disposable Surgical Face Masks (Model: FM-34EE, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-34EE mask are made of spun-bond polypropylene, the middle layer is made of melt-blown polypropylene.
The Disposable Surgical Face Masks (Model: FM-44EE, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, filtration layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-44EE are made of spun-bonded polypropylene, the second layer is made of PE film, the filtration layer is made of melt-blown polypropylene.
The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of aluminum.
The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
The acceptance criteria and study proving the device meets them are detailed below, based on the provided text.
The device in question is the "Disposable Surgical Face Masks (FM-34EE, FM-44EE)".
1. Table of Acceptance Criteria and Reported Device Performance
The device includes two models: FM-34EE (Level 2) and FM-44EE (Level 3). The acceptance criteria and performance are outlined for both levels where applicable.
| Performance Testing | Test Methodology | Acceptance Criteria for Level 2 Barrier | Acceptance Criteria for Level 3 Barrier | Reported Performance (Result for both Levels) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101 | $\geq$ 98% | $\geq$ 98% | Passed (Level 2: average 99.9%, Level 3: average 99.9%) |
| Differential Pressure (mmH2O/cm²) | EN 14683:2019 Annex C | $ |
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