(316 days)
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
The medical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
The provided text describes the regulatory clearance for a Medical Face Mask (K210679) and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device (K200847). This is a submission for a physical medical device, not an AI/ML-driven device, so many of the requested elements for AI/ML studies are not applicable.
Here's a breakdown of the information that is available and a note on the missing information, tailored to the AI/ML context of your request:
Acceptance Criteria and Reported Device Performance
The device is a medical face mask, and its performance is evaluated against established standards for materials used in such masks.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (K2106679) | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Evaluate resistance to penetration by synthetic blood. | 29 Out of 32 pass at 120 mmHg | Lot 1: 32 Out of 32 pass at 120 mmHg | |
| Lot 2: 32 Out of 32 pass at 120 mmHg | ||||
| Lot 3: 32 Out of 32 pass at 120 mmHg | Pass | |||
| Particulate Filtration Efficiency (ASTM F2299) | Measure initial particulate filtration efficiency using monodispersed aerosols (0.1µm latex spheres). | ≥ 98% | Lot 1: 98.9% | |
| Lot 2: 98.9% | ||||
| Lot 3: 98.7% | Pass | |||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Determine bacterial filtration efficiency using a biological aerosol of Staphylococcus Aureus. | ≥ 98% | Lot 1: 99.9% | |
| Lot 2: 99.9% | ||||
| Lot 3: 99.9% | Pass | |||
| Flammability (16 CFR 1610) | Determine flammability characteristics. | Class 1 | Lot 1: Class 1 | |
| Lot 2: Class 1 | ||||
| Lot 3: Class 1 | Pass | |||
| Differential Pressure (Delta P) (EN 14683:2019) | Measure differential pressure between the inside and outside 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.