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Nitrile Exam Gloves (Blue, Black) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is a power free medical glove. The device is provided in blue and black. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in six sizes, which are XS, S, M, L, XL, XXL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.

This document is a 510(k) Summary for Nitrile Exam Gloves (Blue, Black) by Hebei Astro Medical Supply Co., Ltd. It compares the proposed device to a predicate device (K211457) and presents non-clinical test results to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document provides a comprehensive table summarizing the performance testing and biocompatibility testing.

Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not explicitly state the sample sizes used for each specific test within the non-clinical evaluations. The ASTM and ISO standards generally specify sample size requirements, but the report summarizes the results as "Requirement met" or provides a qualitative result without detailing the number of units tested.
• Data Provenance: The tests were conducted by a medical device manufacturer in China (Hebei Astro Medical Supply Co., Ltd.). The data would be considered prospective as it was generated specifically for this 510(k) submission.

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 section is not applicable as the described tests are for physical and chemical properties of a medical glove and biocompatibility. These types of tests do not involve human interpretation or subjective 'ground truth' establishment by experts in the context of medical image analysis or similar diagnostic studies. The "ground truth" here is determined by objective measurements and standardized laboratory procedures.

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

None. Adjudication methods are typically employed in studies involving human interpretation (e.g., radiologists reviewing images) where there might be disagreement in assessments. The tests described for these nitrile exam gloves are objective, laboratory-based physical, chemical, and biological evaluations that yield measurable results against predefined criteria.

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 medical glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This device is a physical medical product, not an algorithm.

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

The "ground truth" for the non-clinical tests is based on objective measurements and standardized laboratory test methods defined by recognized international and national standards (ASTM and ISO). For example:

• Physical Properties: Measured values (tensile strength, elongation, dimensions, powder residue) compared against specified numerical limits in ASTM standards.
• Freedom from Holes: Visual inspection or other methods against a defined AQL (Acceptable Quality Limit).
• Biocompatibility: Observation of biological responses (e.g., skin sensitization, irritation, systemic toxicity) in animal models or in vitro tests against criteria established in ISO standards for acceptable biological reactions.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product where performance is evaluated through standardized non-clinical testing.

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

Not applicable. As stated above, there is no training set for this type of device.

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Vinyl Exam Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The proposed device is a powder free medical glove. The device is available in transparent. The device meets the requirements of ASTM D5250-19: Standard specification for Poly (vinyl chloride) Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.

The provided document describes the acceptance criteria and a study proving the substantial equivalence of Vinyl Exam Gloves (K213019) to a predicate device. This is a 510(k) submission, focusing on non-clinical performance testing rather than clinical trials.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for holes, dimensions, etc.). It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

• Sample Size: Not explicitly stated for specific tests beyond what is implicit in the standard (e.g., ASTM standards typically define sample sizes).
• Data Provenance (Country of Origin): Not explicitly stated, though the manufacturer (Hebei Astro Medical Supply Co., Ltd) is based in China. The testing labs are not identified.
• Retrospective or Prospective: This distinction is not applicable to non-clinical bench testing. These are controlled performance tests conducted on representative samples of the manufactured device.

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 to this type of submission. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO) which define objective, measurable physical and biocompatibility properties. There are no human experts establishing a subjective "ground truth" for these tests in the same way, for instance, a radiologist would read an X-ray. The "experts" are the lab technicians and scientists performing the standardized tests according to defined protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation studies where there is subjective assessment by multiple human readers. For standardized non-clinical performance and biocompatibility tests, the results are objectively measured against established criteria.

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. MRMC studies are specific to AI/CAD systems that assist human readers in interpreting medical images. This submission is for medical gloves, which do not involve human interpretation of images or AI assistance.

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

Not applicable. This device is not an algorithm or AI system. It is a physical medical device.

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

The "ground truth" for the device's performance is defined by the acceptance criteria specified in recognized industry standards (ASTM D5250-19, ASTM D5151-19, ASTM D3767-03 (2020), ASTM D412-16, ASTM D6124-06 (Reapproved 2017), ISO 10993-10:2010, ISO 10993-5:2009, ASTM D6319-10). These standards provide objective, measurable parameters for physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residue) and biological safety (irritation, sensitization, cytotoxicity).

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable. This device is not an AI/ML device that requires a training set.

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