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The Disposable Surgical Face Masks are 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the face mask around the nose. The outer layer is blue, and the colorant material is identified as Phthalocyanine Blue , CAS number: 147-14-8. 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, tie-on, is held in place over the uers's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene. The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided document primarily details the substantial equivalence determination for a Disposable Surgical Face Mask (K211696) to a predicate device (K133070). The acceptance criteria and "study" mentioned in the document refer to a series of non-clinical performance and biocompatibility tests conducted on the proposed device to demonstrate that it meets established standards for surgical masks, specifically ASTM F2100 Level 3 requirements.

Here's the breakdown of the information as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• For the performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The document mentions testing across 3 product lots (LOT NO.: CR202101, CR202102, CR202103). For each lot, 32 samples were tested for Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability.
• For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The document does not specify a numerical sample size but states "Under the conditions of the study" for each. However, these are standard biological evaluation tests that would have followed specific sample size requirements outlined in the referenced ISO standards.
• Data Provenance: The device is manufactured by Anhui Cleanpro Pharmpack Co., Ltd. in Tianchang, Anhui, China. The testing was conducted as part of their submission to the FDA. The tests are non-clinical (laboratory-based) and are likely retrospective in the context of this 510(k) submission, as they were performed to demonstrate compliance of an already manufactured device.

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

This type of information is not applicable to this submission. The "ground truth" here is defined by established international and national standards (ASTM, MIL-M, ISO) for medical device performance and biocompatibility. The tests are objective measurements against these predefined criteria, not subjective expert interpretations of clinical images or findings. Therefore, no "experts" for establishing ground truth in the traditional sense of clinical studies (e.g., radiologists) were involved.

4. Adjudication Method for the Test Set:

This is not applicable. The tests performed are objective, quantitative measurements against specified thresholds, not subjective 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 is not applicable. This submission is for a physical medical device (surgical face mask), not an AI-powered diagnostic or assistive technology.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable. This submission is for a physical medical device.

7. The Type of Ground Truth Used:

The "ground truth" is based on established standard specifications and thresholds for surgical face masks as defined by:

• ASTM F2299-03
• ASTM F1862-17
• ASTM F2101-19
• MIL-M-36954C / 16 CFR 1610
• EN14683:2019
• ISO 10993-5: 2009
• ISO 10993-10: 2010

These standards define the acceptable performance limits for fluid resistance, filtration efficiency, breathability, flammability, and biocompatibility.

8. The Sample Size for the Training Set:

This is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a physical device like a surgical mask based on non-clinical performance and biocompatibility testing. This concept applies to machine learning models.

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

This is not applicable for the reason stated above.

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