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510(k) Data Aggregation
(100 days)
The Disposable Medical Face Mask (Model:LT0819, Ear loops) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The Proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene, iron and zinc. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the acceptance criteria and performance of the "Disposable Medical Face Mask (Model:LT0819, Ear loops)" manufactured by Shenzhen Lyttop Healthcare Limited. The device is classified as a Class II surgical apparel (21 CFR 878.4040) with product code FXX.
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent non-clinical testing to demonstrate its performance against recognized standards, specifically for Level 2 medical masks according to ASTM F2100.
| Test Methodology | Purpose | Acceptance Criteria (Level 2) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | To demonstrate the functionality of the subject device. | 29 out of 32 Pass at 120 mmHg | 3 lots, 32 out of 32 passes at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | 98.69%; 99.43%; 99.41% (for three lots) |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | 99.89%; 99.9%; 99.9% (for three lots) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | To demonstrate the functionality of the subject device. | < 6.0 mmH₂O/cm² | 2.9 mm H₂O/cm²; 3.3 mm H₂O/cm²; 3.3 mm H₂O/cm² (for three lots) |
| Flammability (16 CFR 1610) | To demonstrate the functionality of the subject device. | Class 1 | Class 1; Class 1; Class 1 (for three lots) |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | To demonstrate the biocompatibility of the subject device. | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Biocompatibility - Irritation (ISO 10993-10) | To demonstrate the biocompatibility of the subject device. | Non-Irritating | Under the conditions of the study, the device is non-irritating. |
| Biocompatibility - Sensitization (ISO 10993-10) | To demonstrate the biocompatibility of the subject device. | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that for performance testing, "3 lots" of the device were tested. For Fluid Resistance, 32 samples from each lot were tested (e.g., "32 out of 32 passes"). The specific sample sizes for other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) are not explicitly stated as individual sample counts but are reported as percentages or numerical values per lot.
The data provenance is from non-clinical tests conducted to verify the device's performance against established standards. The country of origin for the testing data is not explicitly stated, but the manufacturer is Shenzhen Lyttop Healthcare Limited, China. The testing is retrospective in the sense that it's conducted on manufactured product samples to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This section is not applicable as the document describes non-clinical performance and biocompatibility testing of a medical device (face mask), not an AI or diagnostic device that requires expert ground truth establishment for a test set. The "ground truth" here is defined by objective physical and biological test standards (e.g., specific filtration percentages, pressure differentials, and toxicity levels).
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. The evaluation is based on direct measurement against predefined scientific and engineering criteria, not subjective expert judgment requiring adjudication.
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 relevant for evaluating the performance of diagnostic imaging or AI devices in assisting human readers, which is not the nature of a disposable medical face mask.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm-only" performance study was not done. The device is a physical medical face mask, not a software algorithm or AI system.
7. The Type of Ground Truth Used
For the performance tests, the "ground truth" used is based on objective, quantitative measurements against established national and international standards.
- Performance (Filtration Efficiency, Fluid Resistance, Differential Pressure, Flammability): The ground truth is defined by the specific thresholds and methodologies outlined in standards such as ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, and 16 CFR 1610. These standards provide clear, measurable criteria for acceptable performance.
- Biocompatibility: The ground truth is defined by the biological response observed in standardized in vitro (cytotoxicity) and in vivo (irritation, sensitization) tests following ISO 10993 guidelines, where "non-cytotoxic," "non-irritating," and "non-sensitizing" are the accepted outcomes.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical product (a face mask) and does not involve an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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