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The White Nitrile Examination Glove,Sterile, is a disposable device intended for medical purposes that is worn on the examiner Is hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards: Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs

The subject device in this 510(k) Notification is White Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, White color, powder free and sterile (Per 21 CFR 880.6250, class I). The White Nitrile Examination Glove ,Sterile, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC).

The provided document is a 510(k) Premarket Notification for a medical device: "White Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim." It outlines the acceptance criteria for the glove's performance, particularly its resistance to chemotherapy drugs, and summarizes the non-clinical testing performed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the chemotherapy drug resistance claim are defined by ASTM D6978-05 standards: Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs. The device's performance is reported as the "Minimum Breakthrough detection time in minutes." The acceptance criteria are implicit in the comparison to the predicate device and the standard, aiming for breakthrough times that prevent drug permeation for a reasonable duration of use. The reported "Minimum Breakthrough detection time" for most drugs is "> 240 Minutes", indicating that no permeation was detected within the maximum test duration.

Other acceptance criteria and performance related to the general glove properties (ASTM D6319-10 Standard specification for Nitrile Examination Gloves) and Biological Evaluation on medical device:

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

The document does not explicitly state the specific sample size used for the chemotherapy drug permeation test set. However, it indicates that the testing was performed "in accordance with ASTM D6978-05 standards." This standard would dictate the sampling methodology and number of replicate tests required.

The data provenance is not explicitly mentioned (e.g., country of origin of the testing lab), but it is a premarket notification from Riverstone Resources SDN BHD in Selangor, Malaysia. The testing would have been conducted by a laboratory to generate data for this submission. The nature of the studies (material property and drug permeation) implies prospective testing specifically for this device submission, not retrospective data.

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 tests described are objective, laboratory-based analyses (material properties, drug permeation, biological evaluations) governed by established ASTM and ISO standards, rather than subjective evaluations requiring expert consensus or interpretation of images. The "ground truth" is determined by the results of these standardized physical and chemical tests.

4. Adjudication method for the test set

This information is not applicable for the reasons stated in point 3. The results are quantitative measurements against predefined thresholds in 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 is not applicable. The device is a physical examination glove, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical examination glove, not an algorithm.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily based on:

• Standardized Physical and Chemical Measurements: Adherence to ASTM D6319-10 (for general glove properties) and ASTM D6978-05 (for chemotherapy drug permeation), which involve objective measurements of tensile strength, elongation, dimensions, pinhole levels, residual powder, and breakthrough times.
• Biological Evaluation Standards: Adherence to ISO 10993-10 for primary skin irritation and dermal sensitization, which are also standardized laboratory tests with objective endpoints.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of physical medical device testing for properties like drug permeation and material strength. The device is not an AI model requiring a training phase.

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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