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510(k) Data Aggregation
(58 days)
Disposable Medical Face Mask (DF3-001)
The Disposable Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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 Proposed device(s) are blue color, and pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene ,metal wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (DF3-001) to verify its performance and safety.
1. Table of acceptance criteria and the reported device performance:
| Item | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance ASTM F1862 | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 29 out of 32 pass at 160 mmHg for level 3 | Lot1, Lot2, Lot3: 32 out of 32 pass at 160 mmHg (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Particulate Filtration Efficiency ASTM F2299 | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | Lot1: 99.35% | |
| Lot2: 99.46% | ||||
| Lot3: 98.69% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS | |||
| Bacterial Filtration Efficiency ASTM F2101 | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | Lot1: 99.88% | |
| Lot2: 99.87% | ||||
| Lot3: 99.88% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS | |||
| Differential Pressure (Delta P) EN 14683 Annex C | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask |
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