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510(k) Data Aggregation
(57 days)
Medical Face Mask (M001)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare persomel 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 a single use, disposable device(s), provided non-sterile.
The Proposed Device Medical Face Mask (Model: M001) is available in white, blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond 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 user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the 510(k) premarket notification for a Medical Face Mask (Model: M001). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K211631) through non-clinical performance testing and biocompatibility assessments, rather than AI/ML algorithm performance.
Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size for training sets, etc.) are not applicable to this submission, as it pertains to a physical medical device (face mask) and not an AI-powered diagnostic or assistive technology.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose (Test) | 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. | Level 2: 29 out of 32 pass at 120 mmHg | ||
| Level 3: 29 out of 32 pass at 160 mmHg | Level 2: 32 out of 32 per lot pass at 120 mmHg for 3 non-consecutive lots tested | |||
| Level 3: 32 out of 32 per lot pass at 160 mmHg for 3 non-consecutive lots tested | 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% | Level 2: Average Result - 99.2% (3 non-consecutive lots tested, sample size 32/lot) | |
| Level 3: Average Result - 99.4% (3 non-consecutive lots tested, sample size 32/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% | Level 2: Average Result - 99.2% (3 non-consecutive lots tested, sample size 32/lot) | |
| Level 3: Average Result - 99.4% (3 non-consecutive lots tested, sample size 32/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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