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The Kimberly-Clark KC300 Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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(s), provided non-sterile.

The Kimberly-Clark* KC 300 Face Mask is a four layer mask, constructed of polyester and polypropylene materials. The outer facing layer is currently made of polypropylene spunbond fabric. With the proposed change, the outer facing layer will be made of polyethylene/polyester material used in a predicate device. The inner facing layer is currently made of polyester cellulose. With the proposed change, the inner facing layer will also be made of polyethylene/polyester material used in a predicate device. Kimberly-Clark KC300 Face Mask(s) is a single use, disposable device, provided nonsterile.

The Kimberly-Clark KC300 Face Mask is a surgical mask that was tested against several ASTM standards and military specifications to ensure its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance:

The device's performance was evaluated against the following criteria, and all reported results met these criteria:

2. Sample Size and Data Provenance:

The document does not specify the exact sample sizes used for each test. The tests were performed according to established ASTM standards (ASTM F2100-11, ASTM F1862-07, ASTM F2101-07, ASTM F2299-03), military specifications (MIL-M369454C), and ISO 10993 standards. These are standard laboratory tests for medical devices, implying the data is likely from prospective testing conducted on device samples. The country of origin of the data is not explicitly stated but is implicitly within the regulatory framework for FDA submission in the USA.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable. The device is a surgical mask, and its performance is evaluated through objective, standardized laboratory tests rather than through expert review of clinical cases or images.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods like 2+1 or 3+1 consensus are used in studies involving subjective interpretation (e.g., image reading by multiple experts). The performance of a surgical mask is determined by quantifiable physical and biological tests.

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

This section is not applicable. MRMC studies evaluate human reader performance, often with and without AI assistance, especially in diagnostic imaging. The KC300 Face Mask is a physical device, and its effectiveness is measured through laboratory tests, not human interpretation.

6. Standalone Performance (Algorithm Only):

This section is not applicable. A surgical mask is a physical device, not an algorithm. Therefore, "standalone" performance in the context of algorithms does not apply.

7. Type of Ground Truth Used:

The ground truth for this device is based on objective, standardized laboratory test results that conform to recognized industry standards (ASTM, MIL-SPEC, ISO). These standards define specific measurable criteria for attributes like filtration efficiency, fluid resistance, flammability, and biocompatibility.

8. Sample Size for the Training Set:

This section is not applicable. Surgical masks are physical devices, and their performance is evaluated directly through testing, not through a "training set" in the context of machine learning. The term "training set" is relevant for AI algorithms.

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

This section is not applicable for the same reason as point 8.

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