(57 days)
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. |
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.