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This product is indicated for infection control practices in the health care industry. When worn properly, the Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.

The Medical surgical mask is a flat style face mask with ear loops and nose clip for fitting around the nose and mouth. The Medical surgical mask has three layers are made of polypropylene nonwoven and the middle layer is made of polypropylene melt-blown. The outer layer is blue, and the colorant material is identified as Pigment Blue K6911D /CAS number: 12239-87-1. The face mask is held in place over the users' nose and mouth by two polyester and spandex elastic bands as ear loops welded to the face mask. The nose clip is made of iron-cored polypropylene, which allows the users to fit the mask around their nose area.

The dimensions of each mask are 175±5 mm in width. The density of the inner and outer layer is 25 gsm, and the density of the middle layer is 35 gsm. The dimensions of nosepiece are 100±5 mm in length and 3±0.5 mm in width. The ear loop is 175±10 mm in length and 3.5±0.5 mm in width. The Medical surgical mask is sold nonsterile and is intended to be single use, disposable device.

The provided text describes the non-clinical testing performed for the Medical Surgical Mask (Model: KF-B P05(L3)) to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The table above primarily lists the performance criteria for Level 3 surgical masks, which both the subject and predicate devices claim to meet. Some direct predicate values are not explicitly stated, but the subject device's performance is compared against the general standard.

2. Sample size used for the test set and the data provenance:

• The document does not specify the exact sample sizes used for each non-clinical test.
• The data provenance is from non-clinical tests performed in a laboratory setting, likely conducted by or for the manufacturer, GUANGDONG KINGFA SCI. & TECH.CO., LTD., which is based in China. The nature of these tests (e.g., ASTM F2101-14, EN 14683: 2019, ASTM F2299-03, ASTM F1862/F1862M-17, 16 CFR Part 1610) indicates they are retrospective laboratory evaluations against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• This information is not applicable as the tests are non-clinical, objective measurements of physical properties based on established ASTM and EN standards. There are no human experts establishing a "ground truth" in the clinical sense for these performance tests. The "ground truth" is defined by the technical specifications of the standards themselves.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not applicable as the tests are objective, quantitative measurements following standardized protocols, not subjective human assessments requiring adjudication.

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:

• This information is not applicable. The device is a medical surgical mask, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This information is not applicable. The device is a medical surgical mask, which is a physical product, not an algorithm. Standalone performance testing refers to the inherent physical measurement capabilities of the mask itself, as detailed in the performance table.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the non-clinical tests is based on established international and national standards and test methods (e.g., ASTM F2101-14, EN 14683: 2019, ASTM F2299-03, ASTM F1862/F1862M-17, 16 CFR Part 1610). These standards define the procedures and acceptance criteria for measuring specific physical properties of medical masks.

8. The sample size for the training set:

• This information is not applicable. The device is a physical product, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

• This information is not applicable for the reasons stated in point 8.

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