Search Results
Found 1 results
510(k) Data Aggregation
(43 days)
The Disposable medical surgical mask is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.
The Disposable medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is 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 Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The Disposable medical surgical mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated steel wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The acceptance criteria and device performance for the "Disposable medical surgical mask" (K212097) are detailed in the provided tables.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (K212097) |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration by synthetic blood | 160 mm Hg | 160 mm Hg (32 out of 32 pass) |
| ASTM F2299 | Sub-micron particulate filtration efficiency at 0.1 micron | ≥ 98% | ≥ 99% |
| ASTM F2101 | Bacterial Filtration Efficiency | ≥ 98% | ≥ 99% |
| EN 14683 Annex C | Differential Pressure | < 6.0 mm H2O/cm² | < 4.9 mm H2O/cm² |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 |
| ISO 10993-10 | Irritation | No irritation effect | No irritation effect |
| ISO 10993-10 | Sensitization | No sensitization effect | No sensitization effect |
| ISO 10993-5 | Cytotoxicity | No cytotoxicity effect | No cytotoxicity effect |
2. Sample size used for the test set and the data provenance:
- ASTM F1862 (Resistance to penetration by synthetic blood): The test involved 32 samples, "32 out of 32 pass at 160 mmHg."
- For other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not explicitly stated in the provided document beyond the quantitative results.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These are non-clinical (laboratory) tests performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This submission concerns a medical mask, and the evaluation is based on non-clinical performance and biocompatibility testing against established ASTM, ISO, EN, and CFR standards. Therefore, clinical expert ground truth is not applicable in the context of this device's submission and approval process. The "ground truth" is defined by the requirements of the standards themselves.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a clinical study involving human readers or cases requiring adjudication. The device performance is assessed through standardized laboratory tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a disposable medical surgical mask, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product (mask), not an algorithm. The performance is inherent to the material and design of the mask as tested in laboratory settings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance evaluation of the mask is based on established national and international standards for medical face masks and biological evaluation of medical devices. These standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, ISO 10993) define the methodologies and acceptance criteria for specific physical, mechanical, and biological properties.
8. The sample size for the training set:
Not applicable. This is a physical medical device (mask), not a machine learning model. There is no concept of a "training set" for its evaluation.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device. The performance is measured directly against predefined standard criteria.
Ask a specific question about this device
Page 1 of 1