(210 days)
The Surgical Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Medical surgical mask is Sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided Sterile.
This document describes the non-clinical testing performed for the HKZ-01 Surgical Mask (subject device) to demonstrate its substantial equivalence to a legally marketed predicate device (Surgical Face Mask, K202843).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | Verify the fluid resistance meets ASTM F2100 Level 2 requirements | 32 Out of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency ASTM F2299 | Verify the particulate filtration efficiency meets ASTM F2100 Level 2 requirements | ≥ 98% | Pass |
| Bacterial Filtration Efficiency ASTM F2101 | Verify the bacterial filtration efficiency meets ASTM F2100 Level 2 requirements | ≥ 98% | Pass |
| Flammability Class 16 CFR 1610 | Verify the flammability meets Class 1 requirements | Class 1 | Pass |
| Differential Pressure (Delta-P) ASTM F2100-19 | Verify the differential pressure meets ASTM F2100 Level 2 requirements |
§ 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.