(46 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The Nordiwell Surgical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ties (polypropylene spunbond white). The mask contains a malleable nosepiece which is centrally positioned between the opposed side edges along the top edge of the mask. The nosepiece is a stable anchor in the vicinity of the nose and readily bent to conform to contours of a person's face. Thus the nosepiece can provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made with natural rubber latex and Shelf-life of the device is 2 years. The subject of this submission is a design change to the ear-loop in the Nordiwell Medical Face Mask(K202615). The ear-loop of the Nordiwell Medical Face Mask(K202615) is changed to tie in the subject device.
This document describes the acceptance criteria and supporting study for the Nordiwell Surgical Face Mask (K210181), which is a surgical face mask.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 Level 3 standard for surgical face masks.
| Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | 160 mmHg | 32 of 32 pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥ 98% at 0.1 micron | > 99.9% |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | ≥ 98% |
| Differential Pressure (Delta P) | ** |
§ 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.