(96 days)
The Disposable Medical Face Mask is 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.
Disposable Medical Face Mask is composed of Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Inner layer Non-woven fabric, Middle Melt-blown Non-woven fabric and outer Non-woven fabric. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Disposable Medical Face Mask feature pleats. Three pleats are used to expand the mask such that it covers the area from the nose to the chin. The type is ear loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-powered medical device. Therefore, most of the requested information about an AI-powered device, such as MRMC studies, training set details, or expert ground truth establishment, is not applicable to this document.
However, I can extract the acceptance criteria and performance data for the physical properties of the face mask as tested.
Here's the relevant information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Purpose | Proposed Device (Reported Performance) | Acceptance Criteria | 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 | 32 out of 32 pass at 160 mmHg (across 3 lots) | 29 out of 32 pass at 160 mmHg for level 3 | PASS |
| Particulate Filtration Efficiency ASTM F2299 | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | Lot1: 98.9%, Lot2: 99.3%, Lot3: 99.5 % | ≥ 98% | 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 | Lot1: 99.88%, Lot2: 99.95%, Lot3: 99.97% | ≥ 98% | 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 | Lot1: 3.3 H2O/cm², Lot2: 3.4 H2O/cm², Lot3: 3.3 H₂O/cm² |
§ 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.