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A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and the examiner.

The subject device of this submission is a natural rubber latex examination glove. The glove is non-sterile and meets the recommendations of ASTM D3578-05(2015). The device is natural in color.

This document describes the premarket notification for the UniTex Non-Sterile, Powder-Free, Latex Examination Glove (K161961). The study aims to demonstrate that this device is substantially equivalent to a legally marketed predicate device (K010879).

Here's the information broken down by your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the requirements of ASTM D3578-05(2015) and specific values for various properties. The reported device performance is presented alongside the predicate device's performance for comparison.

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

The document does not explicitly state the specific sample sizes for each test performed to establish device performance. However, for inspection parameters like "Dimensions", "Physical Properties", "Water Tight Test", and "Visual Defects", AQL (Acceptance Quality Limit) levels and inspection levels (e.g., S-2, G-1) are specified. These AQLs determine the sample size and acceptance criteria for lot release, which implies that a sampling plan was followed according to the referenced standards (e.g., ISO 2859-1:1999).

The data provenance is from prospective testing conducted by UG Global Resources Sdn Bhd to demonstrate compliance with the relevant standards for their device. The manufacturing location and potentially the testing facilities are in Malaysia.

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

This submission is for a medical glove, not an AI/CAD system. Therefore, the concept of "ground truth" as established by medical experts for diagnostic purposes (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for the performance of the glove is established by following standardized ASTM and ISO testing protocols, which are objective and quantitative measurements of physical and chemical properties.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. The tests are objective and based on established industry standards.

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 is not an AI/CAD device.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the device's performance consists of:

• Adherence to ASTM and ISO standards: The device is tested against established specifications outlined in standards like ASTM D3578-05(2015), ASTM D5151, ASTM D5712, ASTM D6124, and ISO 10993-10.
• Quantitative measurements: Physical properties (tensile strength, elongation, dimensions, powder content) and chemical properties (water soluble protein) are measured directly.
• Biocompatibility testing: Standardized in-vivo tests (Primary Irritation Test, Dermal Sensitization Assay) are conducted to determine irritation and sensitization potential.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/CAD device that requires a training set. The performance is assessed through physical and chemical testing.

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

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

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The Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim

Here's a breakdown of the acceptance criteria and the study information for the "Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim," based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported device performance often states "minimum" or "maximum" values that align with the acceptance criteria, suggesting the device met or exceeded these thresholds. For inspection parameters, the text states "In compliance with ASTM D3578-10.ISO 2859-1:1999" and lists the AQLs, implying the device met these standards through the specified inspection levels.

The provided text describes a 510(k) premarket notification for a medical device (examination gloves). This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than a detailed clinical study proving efficacy in the same way a new drug or novel high-risk device might. Therefore, many of the typical questions for a "study that proves the device meets acceptance criteria" are not directly applicable or are answered implicitly through the regulatory framework.

Here's a breakdown of the other requested information based on the provided text:

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: The document does not specify a distinct "test set" sample size in terms of the number of gloves tested for each criterion. Instead, it refers to industry standards (ASTM D3578-10, ISO 2859-1:1999) and inspection levels (S-2, G-1) with Acceptance Quality Limits (AQLs). These standards inherently define the sampling plans used for quality control testing.
• Data Provenance: The manufacturer is "UG Global Resources Sdn Bhd 181 Floor No. 18 Jalan Dato' Abd Rahman 70000 Seremban Malaysia." This indicates the testing and data likely originated from Malaysia. The study is prospective in nature, as it involves testing the manufactured gloves to ensure they meet the defined specifications before market release.

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 question is not applicable to this type of device and submission. The "ground truth" for examination gloves is defined by adherence to established engineering and material science standards (ASTM, ISO), manufacturing quality control processes, and biocompatibility testing, not by expert consensus on clinical interpretation.

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting subjective data, typically in clinical trials involving image analysis or symptom assessment. The tests performed on these gloves are objective physical and chemical measurements.

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 question is not applicable. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiology AI). This device is an examination glove, which does not involve "readers" or "AI assistance."

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

• This question is not applicable. This device is a physical product, not an algorithm, and does not involve AI or standalone algorithmic performance.

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

• The "ground truth" for the performance of these gloves is based on:
  • Established Industry Standards: Primarily ASTM D3578-10 for physical properties and ISO 2859-1:1999 for quality assurance.
  • FDA 1000 ml water test: A specific regulatory test for watertight integrity.
  • Biocompatibility Test Results: To ensure safety in contact with skin.
  • Residual Powder Contents tests: To verify "powder-free" claim.
  • Protein Labeling Claim Level: Chemical testing to quantify protein levels.

8. The sample size for the training set

• This question is not applicable. "Training sets" are relevant for machine learning algorithms. For manufactured goods like gloves, there isn't a "training set" in this context. The manufacturing process is designed and monitored to consistently produce gloves meeting specifications, and ongoing quality control (using the stated inspection levels and AQLs) ensures this.

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

• This question is not applicable as there is no "training set" in the context of this device. The "ground truth" for acceptable glove performance is established by the specifications themselves, derived from regulatory requirements and industry standards.

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A 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 the patient and the examiner.

Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue

1. Table of acceptance criteria and the reported device performance:

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

The document does not explicitly state the specific sample sizes used for each test (e.g., separate sample sizes for physical properties, pinholes, etc.). However, it refers to compliance with ASTM standards, which would dictate the sample sizes and testing methodologies. The data provenance is from Ug Global Resources Sdn Bhd, based in Malaysia, indicating the tests were conducted by the manufacturer for their 510(k) submission. The type of study is retrospective, as it describes tests performed on existing glove samples to demonstrate compliance with standards.

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 to this type of device and study. The "ground truth" for glove performance is established by standardized, objective tests outlined in ASTM and ISO standards, not by expert consensus or interpretation of subjective data.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in medical imaging or clinical trial settings where there's subjective interpretation by experts. For glove testing, the results are quantitative measurements against predefined thresholds in the standards.

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. This is a submission for a medical device (examination gloves), not an AI algorithm or diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

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

7. The type of ground truth used:

The ground truth for this device is based on objective measurements and performance criteria defined by international and national standards, specifically:

• ASTM D 6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D 5151-06: Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D 6124-06: Standard Test Method for Residual Powder on Medical Gloves
• ISO 10993-10:2002: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

These standards provide the methodology and acceptable limits for various properties like dimensions, physical properties, freedom from pinholes, powder residue, and biocompatibility.

8. The sample size for the training set:

This information is not applicable. This is not an AI/machine learning study that involves training and test sets. The glove's performance is evaluated against established standards through direct testing.

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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