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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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