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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 fingers to prevent contamination between patient an examiner.

Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs, meets all the current specifications listed under ASTM Specifications D6319-05 , Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05, Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs.

The provided document describes the acceptance criteria and performance of "Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs" by YTY INDUSTRY (MANJUNG) SDN. BHD. This is a 510(k) premarket notification summary, demonstrating substantial equivalence to a predicate device (K101822).

The study primarily focuses on demonstrating that the gloves meet established industry standards and FDA requirements for patient examination gloves and resistance to chemotherapy drugs.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on ASTM D6319-10 (for examination gloves) and ASTM D6978-05 (for chemotherapy drug permeation), along with FDA 1000ml watertight test and powder content requirements. The reported device performance is for two colors: "Original Blue" and "Cobalt Blue."

Chemotherapy Breakthrough Detection Time (in minutes):

Note: Carmustine and Thiotepa show very low breakthrough times, and a warning is included in the labeling that these chemicals are not recommended for use with these gloves.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves for watertight test, number of gloves for physical properties, amount of chemotherapy testing). However, it implies testing according to ASTM standards, which would define appropriate sample sizes.

The data provenance is not explicitly stated as "retrospective" or "prospective" but represents testing conducted by the manufacturer (YTY INDUSTRY (MANJUNG) SDN. BHD.) for the purpose of this 510(k) submission. The company is located in Malaysia, suggesting the data originates from testing facilities associated with the manufacturer or their designated testing laboratories. Chemotherapy testing was performed by "ARDL CHEMICAL ANALYTICAL SERVICES."

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

This type of submission (for examination gloves) does not typically involve human experts establishing ground truth in the way it would for AI-driven diagnostic devices. The acceptance criteria are based on established industrial standards (ASTM) and regulatory requirements (FDA). The "ground truth" here is the pass/fail criteria defined by these standards for physical properties, barrier integrity, and chemical resistance. Expert involvement would be in interpreting these standards and overseeing the testing, rather than reaching a consensus on individual test outcomes.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is determined by adherence to established, objective test methods and performance specifications from ASTM standards and FDA requirements. There isn't a subjective assessment that requires adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical product (examination gloves), not an AI-driven diagnostic or interpretative system. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Industry Standards: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) and ASTM D6978-05 (Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs).
• Regulatory Requirements: FDA 1000ml watertight test criteria and specific powder content limits.
• Biocompatibility Testing: Standards for primary skin irritation and sensitization tests.

These standards provide objective, measurable criteria for the performance of the gloves.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. The physical properties and chemical resistance are inherent to the product's design and manufacturing process, and performance is evaluated against defined standards, not through machine learning.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for the performance evaluation is established by the accepted and universally applied methods and specifications outlined in the ASTM standards and FDA guidelines.

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