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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

• Width (XS: 75±5mm, S: 85±5mm, M: 95±5mm, L: 105±5mm, XL: 115±5mm, XXL: 125±5mm)
• Length: 230mm min
  • Thickness (Palm: 0.05mm min, Finger: 0.05mm min) | Requirement met |
    | ASTM D412-16 (Physical Properties) | Before Aging:
  • Tensile Strength: 14MPa min
  • Ultimate Elongation: 500% min
    After Aging:
  • Tensile Strength: 14MPa min
  • Ultimate Elongation: 400% min | Requirement met |
    | ASTM D6124-06 (Residual Powder) | Less than 2mg per glove | Requirement met |
    | Biocompatibility Testing |
    | ISO 10993-11:2017 (System Toxicity)| Non-system toxicity | Non-system toxicity |
    | ISO 10993-10:2010 (Sensitization) | Non-sensitizing | Non-sensitizing |
    | ISO 10993-10:2010 (Intracutaneous Reactivity) | Non-irritating | Non-irritating |

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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