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The Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: XS,S,M,L XL and XXL. The subject device is non-sterile.

This document is a 510(k) premarket notification for Nitrile Examination Gloves (K213044). It describes the non-clinical testing performed to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device (K171422).

Here's the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Physical Dimensions (ASTM D6319): Not explicitly stated, but common for such tests to use a statistically representative sample from multiple lots.
• Watertightness (ASTM D5151):
  • XS: 125 gloves
  • S: 125 gloves
  • M: 125 gloves
  • L: 124 gloves
  • XL: 125 gloves
  • XXL: 125 gloves
• Powder Content (ASTM D6124): Not explicitly stated, but typically involves a small sample size per lot.
• Physical Properties (ASTM D412): Not explicitly stated, but typically involves a small number of samples (e.g., 5-10 per lot) for before and after aging tests.
• Biocompatibility (ISO 10993-5, -10, -11): The sample size refers to the size of the test articles (e.g., extracts of the glove material). Specific numbers of biological samples (e.g., cells, animals) are not provided in this summary but are defined by the respective ISO standards.

Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that the manufacturer is "Jiangsu Huayuan Medical Technology Co., Ltd." in China, it is highly probable that the non-clinical testing was conducted in China. These non-clinical tests are generally prospective, as they involve manufacturing the device and then testing its properties according to established standards.

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 medical device (nitrile examination gloves) against recognized international standards. It does not involve human interpretation of medical images or diagnoses that would require expert radiologists or pathologists to establish "ground truth." The ground truth for these tests is established by the specifications defined in the relevant ASTM and ISO standards, which are objective and quantitative measurements (e.g., length, width, tensile strength, freedom from holes, powder content, cytotoxicity, irritation, sensitization, systemic toxicity).

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

Not applicable. As described above, this document pertains to non-clinical objective testing against established standards, not human interpretation requiring adjudication.

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-powered diagnostic device, but rather a physical medical device (examination gloves). Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this device's performance is established by the objective physical and chemical properties and biological responses as defined by the following international consensus standards:

• ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application.
• ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (implicitly used for tensile strength and elongation metrics).
• ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
• ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
• ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The performance is assessed through physical and biological testing that compares the device to predetermined specifications in established standards.

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

Not applicable. There is no training set for this type of device.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification from the FDA for "Synthetic Vinyl Examination Gloves." This type of document is for medical devices that are deemed substantially equivalent to a predicate device, and thus, typically does not involve the rigorous clinical studies that would require extensive details on acceptance criteria and study methodologies as one might find for a novel device or software.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K153028) by comparing performance against recognized ASTM and ISO standards for examination gloves. Therefore, the questions related to AI performance, reader studies, ground truth establishment, and training sets are not applicable to this device.

Here's an analysis of the available information regarding acceptance criteria and testing, tailored to the context of a medical glove:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Synthetic Vinyl Examination Gloves" are based on recognized industry standards for medical gloves, primarily ASTM D5250, ASTM D5151, and ASTM D6124, along with biocompatibility standards ISO 10993-5 and ISO 10993-10. The device's reported performance demonstrates compliance with these standards.

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample sizes used for each of the non-clinical tests (e.g., number of gloves tested for tensile strength, holes, etc.). The tests refer to compliance with ASTM and ISO standards, which typically define their own sampling plans.
   • Data Provenance: The tests were conducted by the manufacturer, Jiangsu Huayuan Medical Technology Co., Ltd. The document does not explicitly state the country of origin of the data beyond the manufacturer's location in China. The testing appears to be prospective for the subject device to demonstrate compliance with the stated standards.

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

   • Not Applicable. For non-clinical tests of physical properties and biocompatibility of medical gloves, "ground truth" is established by laboratory measurement against predefined objective criteria in the standards, not by expert consensus or subjective assessment.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic interpretations, especially in image analysis where human readers evaluate cases. For objective laboratory testing, results are determined by instrumentation and adherence to standard protocols.

4. 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 device is a medical glove, not an AI software or a device that involves human reader interpretation in a diagnostic context.

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

   • Not Applicable. This device is a physical medical glove and does not involve any algorithms or AI for standalone performance.

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

   • For the physical and performance tests, the "ground truth" is defined by the objective, quantitative specifications outlined in the referenced national and international standards (ASTM D5250, ASTM D5151, ASTM D6124).
   • For biocompatibility tests, the "ground truth" is established by the biological response observed in standardized in vitro (cytotoxicity) and in vivo (irritation, sensitization) tests as per ISO 10993-5 and ISO 10993-10, evaluated against predefined criteria for an acceptable biological reaction.

7. The sample size for the training set:

   • Not Applicable. This device is a medical glove. It does not involve a "training set" in the context of machine learning or AI.

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

   • Not Applicable. As there is no training set, this question is not relevant.

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