Search Results
Found 1 results
510(k) Data Aggregation
(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 |
Ask a specific question about this device
Page 1 of 1