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510(k) Data Aggregation
(54 days)
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile.
The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
This document describes the acceptance criteria and the study results for the Guangdong Golden Leaves Technology Development Co., LTD's Medical Protective Mask (models 8862, 8862A, 8862B, 8862C, 8862D, 8862E), as presented in their 510(k) Summary (K223068).
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 standard for Medical Face Mask Materials. All models (Level 1, Level 2, and Level 3) of the Medical Protective Mask are stated to meet the performance requirements of all three levels.
| Test Item | Test Method | Acceptance Criteria (Level 1) | Reported Performance (Level 1) | Acceptance Criteria (Level 2) | Reported Performance (Level 2) | Acceptance Criteria (Level 3) | Reported Performance (Level 3) | Verdict |
|---|---|---|---|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101-19 | ≥ 95% | Pass | ≥ 98% | Pass | ≥ 98% | Pass | Pass |
| Differential Pressure (Delta-P) | EN 14683: 2019, Annex C | < 5.0 mm H2O/cm² | Pass | < 6.0 mm H2O/cm² | Pass | < 6.0 mm H2O/cm² | Pass | Pass |
| Particulate Filtration Efficiency (0.1 µm) | ASTM F2299 | ≥ 95% | Pass | ≥ 98% | Pass | ≥ 98% | Pass | Pass |
| Resistance to Synthetic Blood Penetration | ASTM F1862/F1862M-17 | Pass at 80 mmHg | Pass | Pass at 120 mmHg | Pass | Pass at 160 mmHg | Pass | Pass |
| Flammability | 16 CFR Part 1610 | Class 1 | Pass | Class 1 | Pass | Class 1 | Pass | Pass |
Biocompatibility Testing
| Title of the test | Reference for Test method | Acceptance Criteria | Test Results |
|---|---|---|---|
| In vitro Cytotoxicity Test | ISO 10993-5:2009 | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Skin Sensitization Test | ISO 10993-10:2010 | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin Irritation Test | ISO 10993-10:2010 (Part 23: Tests for irritation and skin sensitization) | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each performance and biocompatibility test. It indicates that the tests were conducted according to the specified ASTM and ISO standards, which would implicitly define minimum sample sizes for valid results. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but it's generated for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this device is based on standardized performance and biocompatibility testing according to recognized international standards (ASTM, ISO, EN, 16 CFR). These standards define specific methodologies and criteria, rather than relying on expert consensus for interpreting test results.
4. Adjudication Method for the Test Set
Not applicable. The assessment relies on objective measurements against predefined thresholds as per the referenced standards, not on an adjudication process involving human reviewers for interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The Medical Protective Mask is a physical barrier device, and its effectiveness is determined by its material properties and physical performance as measured by objective tests.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies conducted were standalone performance tests of the device itself, without human-in-the-loop performance evaluation. The performance criteria (e.g., filtration efficiency, fluid resistance) are objective measurements of the mask's physical characteristics.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Medical Protective Mask's performance is based on established international standards and testing methodologies. For example:
- Performance data: Directly measured physical properties (e.g., filtration rates, pressure differential, fluid penetration, flammability) against the numerical thresholds defined by ASTM F2100:2019, EN 14683: 2019, and 16 CFR Part 1610.
- Biocompatibility data: Laboratory test results (cytotoxicity, sensitization, irritation) against the criteria defined by ISO 10993-5:2009 and ISO 10993-10:2010.
8. The Sample Size for the Training Set
Not applicable. This device is a medical mask evaluated by its physical properties and biocompatibility. There is no "training set" in the context of machine learning or AI models. The testing described is for the final product's performance validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device. The regulatory submission focuses on demonstrating that the physical device meets established performance and safety standards through non-clinical testing.
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