(164 days)
The surgical masks are 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.
The ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.
The provided document is a 510(k) Premarket Notification for the ECOMA Level 2 Disposable Surgical Mask with Ear Loops. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study of the device itself. Therefore, many of the requested categories regarding human expert studies, multi-reader multi-case studies, and human-in-the-loop performance are not applicable to this type of regulatory submission for this medical device.
Here's the information extracted from the document regarding acceptance criteria and performance, as applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM F2101-Bacterial Filtration Efficiency (BFE) | ≥ 98% Average BFE for all samples tested | 96/96 samples passed ≥ 98% Average BFE (3 lots, 32 samples per lot with a lot size of 200,000 each) |
| ASTM F2299-Particulate Filtration Efficiency (PFE) | ≥ 98% Average PFE for all samples tested | 96/96 samples passed ≥ 98% Average PFE (3 lots, 32 samples per lot with a lot size of 200,000 each) |
| Differential Pressure | Samples must be |
§ 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.