Search Results

Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable devices provide non-sterile.

The subject device is a three-layer and flat-pleated mask. The mask materials consist of non-woven/ outer layer (polypropylene spunbond), melt blown/ filter layer (polypropylene melt-blown) and non-woven/ inner layer (polypropylene spunbond). Each mask contains the ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece to provide a firm fit over the nose.

The subject device is a single-use, disposable device, provided non-sterile.

This document is a 510(k) summary for a Disposable Surgical Face Mask. The information provided is primarily focused on the non-clinical performance and biocompatibility testing of the device to demonstrate substantial equivalence to previously cleared predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes for the individual performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability) or the biocompatibility tests (Cytotoxicity, Irritation, Sensitization). The testing methods are referenced (e.g., ASTM F1862/F1862M-17, ASTM F2299-03, ASTM F2101-14, EN 14683: 2019, 16 CFR Part 1610, ISO 10993-5: 2009, ISO 10993-10: 2010), which would typically define the sample sizes used for such tests.

The data provenance is not mentioned in terms of country of origin or whether the data was retrospective or prospective, as these are non-clinical (laboratory) tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device and testing. The "ground truth" for non-clinical performance and biocompatibility of a surgical face mask is established by validated standardized test methods and their predefined acceptance criteria, not by expert consensus or interpretations of images/data by human experts.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies when interpreting subjective outcomes or discrepancies among multiple readers/experts. For these non-clinical tests, the results (e.g., pass/fail, numerical values) are objective outcomes of the specified test methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. This document describes a surgical face mask, which is not a diagnostic device.

6. Standalone (Algorithm Only) Performance:

Not applicable. There is no algorithm or AI component in a Disposable Surgical Face Mask. The device is a physical product, and its performance is measured through direct laboratory testing.

7. Type of Ground Truth Used:

The ground truth for the device's performance is established by the standardized test methods and their predetermined acceptance criteria outlined in the referenced standards (e.g., ASTM F2100: 2019, ISO 10993 series). These standards define what constitutes a "PASS" for each characteristic (e.g., ≥98% for PFE, <6.0 mm H2O/cm² for Differential Pressure).

8. Sample Size for the Training Set:

Not applicable. There is no "training set" for this device. Training sets are relevant for machine learning algorithms, which are not part of a surgical face mask.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

Ask a specific question about this device