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A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

This document describes the premarket notification (510(k)) for a medical device, specifically "Black Nitrile Powder Free Patient Examination Glove, Non Sterile". It is not an AI/ML medical device submission. Therefore, the questions related to AI/ML specific studies, such as MRMC studies, ground truth establishment by experts, and training/test set sample sizes for AI/ML models, are not applicable.

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (K190942) by meeting established performance standards for patient examination gloves.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance & Comparison Analysis

The document provides a detailed comparison in "Table 1" and further test results in section "7.0 Summary of Non-Clinical Testing".

2. Sample sizes used for the test set and data provenance:

• Physical Properties (Tensile Strength, Elongation): Not explicitly stated as a "test set" in the context of AI/ML, but performance data is provided for various glove sizes (XS, S, M, L, XL, XXL). The test method ASTM D412 typically involves testing multiple specimens from a sample.
• Dimension: Various sizes (X-Small, Small, Medium, Large) are listed with their measured dimensions. The number of samples for measurement is not explicitly given, but it is expected to be a representative sample for each size.
• Watertight:
  • Sample Size: 200 pieces for each size (XS, S, M, L, XL, XXL).
  • Data Provenance: The standard is ASTM D5151. Based on the context of a 510(k) submission, this data would be generated from prospective testing of the manufactured device lots under controlled conditions, likely at the manufacturer's facility or a contracted lab. The country of origin for the manufacturing is Thailand.
• Residual Powder:
  • Sample Size: 5 pieces.
  • Data Provenance: Standard is ASTM D6124. This is also prospective testing.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity):
  • Sample Size: Not explicitly stated as a number of devices, but the studies describe using rabbit skin and guinea pigs (for sensitization) and mice (for systemic toxicity). Typical animal study protocols would define the sample size of animals.
  • Data Provenance: Standards are ISO 10993-10 and ISO 10993-11. These are prospective animal studies conducted in a lab environment.

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

Not applicable. This is a traditional medical device (glove) clearance, not an AI/ML device relying on expert labeling for ground truth. The "ground truth" is established by adherence to recognized international and national consensus standards (ASTM, ISO) for physical, chemical, and biological properties, which are quantitatively measured.

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

Not applicable. This is not an AI/ML study design that would require human expert adjudication of ambiguous cases. Performance is based on objective measurements against established standard criteria.

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 not an AI/ML diagnostic or assistive device.

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

Not applicable. This is not an AI/ML device.

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

The ground truth for device performance is based on established national and international consensus standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series) that define the test methods and acceptance criteria for patient examination gloves. These are objective, measurable parameters (e.g., tensile strength in MPa, elongation in %, presence/absence of holes, residual powder in mg, biological responses in animal models).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set.

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