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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 | < 6.0 mmH20/cm² | Pass |
| ASTM F2100 Level 2 ASTM F2100 | Verify all ASTM F2100 Level 2 requirements are met | Meets requirements at Level 2 | Pass |
| Biocompatibility Skin Irritation ISO 10993-10 | Verify the device is non-irritating under ISO 10993-10 testing | Under the conditions of the study, non-irritating | Pass |
| Biocompatibility Skin Sensitization ISO 10993-10 | Verify the device is not a sensitizer under ISO 10993-10 testing | Under the conditions of the study, non-sensitizing | Pass |
| Biocompatibility Cytotoxicity ISO 10993-5 | Verify the device is not cytotoxic under ISO 10993-5 testing | Under the conditions of the study, non-cytotoxic | Pass |
| EO/ECH Residues ISO 10993-7 | Verify low levels of sterilant residuals | EO ≤ 4mg/device, ECH ≤ 9mg/device | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Three nonconsecutive lots were tested to demonstrate that the subject device met the standard and the test methodology." (Page 4) Specific sample numbers for each test (e.g., how many masks were tested for fluid resistance) are not provided.
- Data Provenance: Not explicitly stated as country of origin, but the submission is from Nanjing 3H Medical Products Co., Ltd., China. The tests are non-clinical, likely conducted in a laboratory setting. The data is retrospective in the sense that these tests were conducted on completed products prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable as the tests are non-clinical, performance-based tests, not requiring expert ground truth for interpretation. The ground truth is defined by the established industry standards (e.g., ASTM, ISO).
4. Adjudication Method for the Test Set
- This information is not applicable as the tests are non-clinical, objective measurements against defined standards, not requiring adjudication by multiple readers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "No clinical testing was included in this submission." (Page 5)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a surgical mask, not an algorithm or AI-powered system. The testing performed is physical and biological performance testing of the mask itself.
7. The Type of Ground Truth Used
- The ground truth for these non-clinical tests is established by objective, quantitative performance criteria defined by recognized national and international standards such as ASTM F1862, ASTM F2299, ASTM F2101, 16 CFR 1610, ASTM F2100-19, and ISO 10993 (various parts).
8. The Sample Size for the Training Set
- This information is not applicable as this is a physical medical device (surgical mask), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as this is a physical medical device (surgical mask) and does not involve a training set.
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