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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 patient and examiner.

Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

This document is a 510(k) premarket notification for a medical device: "Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)" manufactured by WRP Asia Pacific Sdn Bhd.

Based on the provided information, the acceptance criteria and the study that proves the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but typically involves multiple samples per batch/test condition to derive an average. The standards (ASTM D412-16) would specify the required sample size.
• Dimension: Not explicitly stated, but typically involves multiple samples per batch/test condition to derive an average. The standards (ASTM D3767 - 03(2014)) would specify the required sample size.
• Watertight:
  • Sample Size: 315 pieces
  • Data Provenance: The data is from non-clinical testing performed on the device itself. The country of origin of the data is not specified, but the manufacturer is WRP Asia Pacific Sdn Bhd in Malaysia. This is prospective testing on the manufactured device.
• Residual Powder:
  • Sample Size: 5 pieces
  • Data Provenance: Non-clinical testing on the device. Country of origin not specified, manufacturer is Malaysian. This is prospective testing.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): These tests were performed, and results indicated "Passes" or "Not a primary skin irritant/contact sensitizer" or "Exhibit severe cytotoxicity reactivity at 100%, 66%, and 44% extract concentration. Moderate cytotoxicity reactivity at 30%, mild cytotoxicity reactivity at 20% and slight cytotoxicity reactivity at 15% extract concentrations." and "It is concluded that the extracts (polar and non-polar) of the product did not show any systemic toxicity." The exact number of samples (and animals for in-vivo tests) used for these biocompatibility tests is not detailed in the provided summary, but the standards (ISO 10993 series and Consumer Product Safety Commission regulations) would dictate the sample sizes. Data provenance is non-clinical testing on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document describes non-clinical performance testing of a physical medical device (gloves). The "ground truth" for these tests is established by published, internationally recognized standards (ASTM, ISO, FDA 21 CFR, CPSC regulations) and the objective measurements derived from these tests. These studies do not involve human experts establishing a subjective ground truth, as would be the case for AI/diagnostic imaging devices. Therefore, this information is not applicable.

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

Not applicable. This is not a study involving subjective human interpretation that would require an adjudication method. The testing involves objective physical and chemical measurements against pre-defined 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 a 510(k) submission for a physical medical device (examination gloves), not an AI/Software as a Medical Device (SaMD) that would typically involve human readers or AI assistance.

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

Not applicable. This is for a physical medical device.

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

The "ground truth" for the performance characteristics of these gloves is defined by:

• Standardized Test Methods: ASTM D412-16, ASTM D3767 - 03(2014), ASTM D5151-06, ASTM D6124-06.
• Regulatory Standards: FDA 21 CFR 880.6250.
• Biocompatibility Standards: ISO 10993-10:2002(E), ISO 10993-5:2009 (E), ISO 10993-11:2017 (E), and Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.

These standards provide objective, measurable criteria for the glove's performance.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

Not applicable. No training set is involved.

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