(232 days)
Wilson Tech 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. Wilson Tech Disposable Medical Face Mask is single use, disposable device, provided non-sterile.
Wilson Tech Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of galvanized iron wire coated with polyethylene to provide a firm fit over the nose.
The provided document is a 510(k) premarket notification for a medical device, specifically the Wilson Tech Disposable Medical Face Mask. It details the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a detailed table comparing the subject device (Wilson Tech Disposable Medical Face Mask) with the primary predicate device (DemeMASK Surgical Mask - K201479). The key acceptance criteria are based on surgical mask performance standards, primarily ASTM F2100 Level 3.
| Test Methodology | Purpose of the test | Acceptance criteria | Test Results (Wilson Tech Disposable Medical Face Mask) |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | Performed in accordance with ASTM F2101 to determine the bacterial filtration efficiency using a biological aerosol of Staphylococcus aureus. | Level 3: ≥98% | 32/32 Passed at ≥99.3% |
| Particulate Filtration Efficiency (PFE) | Performed in accordance with ASTM F2299 to determine the particle filtration efficiency using latex spheres. | Level 3: ≥98% | 32/32 Passed at ≥99.28% |
| Differential Pressure (delta-P) | Performed in accordance with MIL-M-36954C. Measures the breathability 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.