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Black Pearl Nitrile Examination Glove is a disposable device, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Black Pearl Nitrile Examination Glove is a single use examination glove, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The nitrile glove is an ambidextrous, beaded cuff and black in colour. It meets the performance requirements in accordance with ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

This looks like a 510(k) Premarket Notification for a medical device (Black Pearl Nitrile Examination Glove). For this type of device, the acceptance criteria and supporting studies are focused on performance, safety, and biocompatibility, rather than clinical efficacy studies often seen with AI/ML devices.

Here's an analysis of the provided information, framed by your request:

Acceptance Criteria and Study for Black Pearl Nitrile Examination Glove

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the standards ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Applications) and ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves).

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

• Dimensions: 13 pieces of gloves from each size (XS, S, M, L, XL) for each parameter (length, width, thickness). Lot size for sampling was 35,001 to 150,000, with an inspection level of S-2 and AQL of 4.0.
• Freedom from Holes: 200 pieces of M-size gloves. Lot size for sampling was 35,001 to 150,000, with an inspection level of G-1 and AQL of 2.5.
• Physical Properties: 13 pieces of M-size gloves. Lot size for sampling was 35,001 to 150,000, with an inspection level of S-2 and AQL of 4.0.
• Powder-free Residue: 5 pieces of gloves.
• Skin Irritation Test: 6 New Zealand White rabbits (3 for polar extracts, 3 for non-polar extracts).
• Skin Sensitization Test: 30 guinea pigs (5 for polar solvent control, 10 for polar test item extract, 5 for non-polar solvent control, 10 for non-polar test item extract).
• In vitro Cytotoxicity: L-929 mouse fibroblasts cells.
• Acute Systemic Toxicity Test: 20 Swiss Albino mice (4 groups of 5 males each).

Data Provenance: The document does not explicitly state the country of origin for the testing facilities or the specific animal vendors/data source, but the submitter is from Malaysia. These are prospective tests performed specifically for this 510(k) submission.

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

These tests are standardized laboratory and in-vivo animal tests, not typically requiring "experts" in the sense of clinical reviewers establishing ground truth for diagnostic or AI systems. The "ground truth" is established by the well-defined and validated methodologies of the ASTM and ISO standards themselves. The results are quantitative measurements or qualitative observations by laboratory personnel trained in those specific methods.

4. Adjudication Method for the Test Set

Not applicable in the context of these types of performance and biocompatibility tests. Results are generally objective measurements or direct observations against a standard, not requiring multi-expert 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

Not applicable. This device is an examination glove, not an AI/ML-based diagnostic system.

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

Not applicable. This device is an examination glove, not an AI/ML-based diagnostic system.

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

The "ground truth" for these tests is based on:

• Standardized measurement protocols: For physical dimensions, tensile strength, elongation, and powder residue.
• Defined biological reactions: For freedom from holes (water leak detection) and biocompatibility tests (observed biological responses in animals or cell cultures according to ISO guidelines).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the typical sense. The performance characteristics of the glove are inherent to its manufacturing process and material properties, validated by testing against established standards.

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

Not applicable. There is no training set for this type of device.

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Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner and the patient.

The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10. The device is Blue in color.

This document is a 510(k) Premarket Notification for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue. It demonstrates substantial equivalence to a predicate device (K112012). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance specifications of the glove and the testing conducted to show compliance with those specifications and equivalence to the predicate device.

Here's an breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several characteristics and their corresponding standards/performance for the new device (K162510) and the predicate device (K112012). This can be structured as follows:

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

• Sample Size: The document refers to "Inspection Level-S-2" and "Inspection Level-G-1" with associated AQLs (Acceptance Quality Limits) for various tests (e.g., Dimensions, Physical Properties, Freedom from Pinholes). These imply specific sampling plans outlined in the relevant ASTM standards (ASTM D 6319-10, ASTM D 5151-06, etc.). However, the exact number of units tested is not explicitly stated in this summary document.
• Data Provenance: Not explicitly stated in terms of country of origin of the data or whether it was retrospective/prospective. As this is a premarket submission for a physical device, the testing would have been conducted in a lab environment.

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

• This is not applicable in the context of this device. This document is about a physical medical device (gloves), not an AI/software device requiring expert interpretation of medical images or data. The "ground truth" for glove performance is established by adherence to specified physical and chemical characteristics and recognized ASTM and ISO standards, not by expert consensus on clinical interpretation.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" is determined by objective physical and chemical testing methods (e.g., measuring dimensions, tensile strength, performing water leak tests, chemical residue analysis, biocompatibility assays), not through human adjudication of differing interpretations.

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

• No, an MRMC study was not done. This type of study is relevant for AI/imaging devices where human reader performance is a key metric. For examination gloves, the focus is on physical and chemical properties and safety/performance equivalence.

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

• Not applicable. This is not an algorithm or AI device. The "performance" is the inherent physical and chemical properties of the glove.

7. The Type of Ground Truth Used

• The ground truth for this device is based on objective, standardized measurements and test methods defined by recognized national and international standards, primarily ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. This includes:
  • Physical Specifications: Dimensions (length, width, thickness), tensile strength, elongation.
  • Functional Testing: Freedom from pinholes (water integrity).
  • Chemical Analysis: Powder residue.
  • Biocompatibility Testing: Dermal sensitization and primary skin irritation, conducted according to ISO 10993-10 and 16 CFR Part 1500.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, this is not a machine learning or AI device.

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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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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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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

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