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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.

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01ar2 Standard Specification for Latex Examination Gloves for Medical' Application.

The document provided is a 510(k) Premarket Notification from the FDA for a medical device: "Non-Sterile Powder Free Green Latex Patient Examination Gloves with Nopal/Aloe Vera/Vitamin E and Donning Aid Coating, and With Protein Labeling Claim (<50uG/G)".

The document describes the device's acceptance criteria and how its performance was demonstrated.

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Water Tight Test Results (LOT# 2206):

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

• Sample Size:
  • For Water Tight Test: 125 pieces per size (X-Small, Small, Medium, Large) for both un-aged and aged conditions, totaling 1000 gloves.
  • For Physical Properties (Tensile Strength, Ultimate Elongation): Lot# 2206 was tested, but specific sample sizes for each measurement are not explicitly stated beyond lot number. However, ASTM D3578-01aE2 typically defines sampling plans.
  • For Residual Powder Content: Not specified beyond a "Range" and "Mean."
  • For Biocompatibility: "the gloves passed the tests in question records" in Appendix M suggests testing was performed according to guidelines, but sample size is not stated.
• Data Provenance: The document does not specify the country of origin of the data. It implies retrospective testing on manufactured gloves (Lot# 2206).

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

This information is not applicable to this type of device (patient examination gloves). The "ground truth" for the performance of these gloves is established through standardized physical, chemical, and biological tests based on established specifications like ASTM-D3578-01aE2 and FDA requirements, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable. As stated above, performance is measured against objective standards, not through adjudication of expert interpretations.

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 physical, non-AI medical device (patient examination gloves), and therefore, no MRMC study involving human readers or AI assistance was performed.

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 device, not an algorithm, so no standalone algorithm performance study was done.

7. The Type of Ground Truth Used:

The ground truth used is based on:

• Standard Specifications: ASTM-D3578-01aE2 "Standard Specification for Latex Examination Gloves for Medical Application."
• FDA Internal Requirements: For water tight tests, residual powder content, and specified protein labeling claim (<50 µg/g).
• Biocompatibility Standards: Implied by "passed the tests in question" as per Appendix M.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for this type of device.

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