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A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile. The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free.

The provided text is a 510(k) premarket notification for a medical device: "Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy studies often associated with AI/ML devices. Therefore, the questions related to AI/ML device testing (e.g., ground truth establishment by experts, MRMC studies, training set details) are not applicable to this submission.

However, I can extract the acceptance criteria and performance data for the physical characteristics of the examination gloves, which are the relevant "performance" metrics for this device.

Here's the information based on the provided text, focusing on the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Properties: Data is provided for each size (XS, S, M, L, XL). The specific sample size for each test (e.g., number of gloves tested for tensile strength) is not explicitly stated, but the results represent the performance across these sizes.
• Dimension: Data is provided for each size (XS, S, M, L, XL).
• Watertight:
  • XS & XL: Sample size 200 pcs each.
  • S, M, L: Sample size 500 pcs each.
  • Data Provenance: The document does not specify the country of origin where the testing was conducted or if it was retrospective/prospective. It's non-clinical lab testing.
• Residual Powder: Sample size: 5 pcs.
• Extractable Protein Content: Sample size: 3 pcs.

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

Not applicable. This device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biocompatibility tests, not clinical expert review of images or medical data. The "ground truth" is defined by the parameters of the ASTM standards and the test results.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements against predefined standards, not subjective assessments requiring multiple reviewers or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This is not an AI/ML device or a diagnostic device that would typically undergo MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device (glove), not an algorithm.

7. The Type of Ground Truth Used

The ground truth is established by international and national standards (e.g., ASTM D3578, ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ASTM D5712-99, ISO 10993 series) for physical properties, biocompatibility, and manufacturing quality of medical gloves. These standards define the measurable acceptance criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of Study Type:

The document describes non-clinical performance testing against established industry standards (ASTM, ISO) to demonstrate that the Natural Rubber Latex Examination Glove meets all relevant safety and performance requirements and is substantially equivalent to a legally marketed predicate device (K202377). It's a bench testing/laboratory study based on adherence to quantitative standards rather than a clinical trial or AI/ML model validation study.

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The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The patient examination glove 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.

Class I natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3578-95.

The provided text describes the acceptance criteria and performance data for the "DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING)".

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state a specific sample size (e.g., number of gloves tested). However, for the "Watertight" test, it refers to "Single Sampling Plan, S-4, AQL 4.0" and "Multiple Sampling Plan, GII, AQL 4.0". These are sampling plans from quality control standards, which implicitly define sample sizes based on lot size and AQL. The specific sample sizes are not directly provided in the text.
• Data Provenance: The tests were conducted by WRP Specialty Products Sdn. Bhd. in Malaysia, as indicated by the company's address. The data is retrospective, as it's a summary of performance data collected prior to the 510(k) submission date of January 12, 1999.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as the device is a patient examination glove and the acceptance criteria are based on objective physical and chemical properties as defined by ASTM standards and FDA watertight test requirements, not expert interpretation of medical images or conditions.

4. Adjudication method for the test set:

• This information is not applicable as the acceptance criteria are based on objective, quantitative measurements against established standards, not on 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 information is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.

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

• This information is not applicable as the device is a medical glove, not an algorithm. The performance evaluation is of the physical product itself.

7. The type of ground truth used:

• The "ground truth" for this device is based on objective, quantitative measurements defined by:
  • ASTM D3578-95 standard for natural rubber latex patient examination gloves.
  • FDA 1000 ml watertight test.
  • Specific thresholds for powder content and protein content.

8. The sample size for the training set:

• This information is not applicable as the device is a physical product (glove) and not a software or AI model that requires a training set in the conventional sense. The manufacturing process is subject to quality control, which involves sampling, but this is distinct from an AI 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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