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Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. It details the device's characteristics and compares them to a predicate device to establish substantial equivalence.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The device's performance is compared against established standards, primarily ASTM D6319-10 (Reapproved 2015) for Nitrile Examination Gloves for Medical Application, along with other ISO and ASTM standards for biocompatibility and specific tests.

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

The document does not explicitly state a specific numerical sample size for each test. However, it references industry standards like Inspection Level I, AQL 2.5, for Freedom from Pinholes which implies a statistically determined sample size for quality control testing of physical properties. For residual powder, it states "Checked on 5pcs sub-samples (N=5)".

• Data Provenance: The document does not explicitly state the country of origin of the data collection or if the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests performed (material properties, biocompatibility), these are typically controlled laboratory tests conducted during the device's development phase, likely in China where the manufacturer is located.

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

This 510(k) submission is for patient examination gloves, which are assessed based on established physical, chemical, and biological performance standards (e.g., ASTM, ISO). The "ground truth" is defined by meeting these predefined quantitative criteria. Therefore, there isn't a concept of "experts establishing ground truth" in the same way as with diagnostic AI. The performance is objectively measured against the specified thresholds in the standards by qualified testing laboratories.

4. Adjudication Method for the Test Set:

Not applicable in this context. The testing involves objective measurements against pre-defined numerical and qualitative standards, not human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a medical device (patient examination gloves) that does not involve diagnostic interpretation or human-in-the-loop performance improvement in the typical sense of an AI/imaging device. Clinical testing was explicitly stated as "not needed for this device."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical product, not a software algorithm. The "performance" is its intrinsic physical and biological characteristics.

7. The Type of Ground Truth Used:

The ground truth is based on established industry standards and regulatory requirements (e.g., ASTM D6319, ISO 10993, 21 CFR 800.20) for physical properties, chemical composition, and biocompatibility of patient examination gloves. These are objective, measurable performance criteria.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a "training set." The device's characteristics are determined by its manufacturing process and tested against objective standards, not by an algorithm learning from data.

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

Not applicable for the reason stated in point 8.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

This document pertains to the 510(k) premarket notification for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The information provided heavily focuses on proving substantial equivalence to a predicate device through non-clinical performance data, primarily compliance with established ASTM and ISO standards for medical gloves.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for dimensions, pinholes, tensile strength). It refers to compliance with standards like ASTM D5250. These standards typically define the sampling plans.
• Data Provenance: The tests were conducted by the manufacturer, Shandong Jieshi Medical Products Co.,Ltd, located in China. The data would be considered prospective, as it was generated to support the 510(k) submission for this specific device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document concerns medical device performance testing, not diagnostic AI. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation (like radiologists for imaging) is not applicable here. The "ground truth" for these tests is defined by established regulatory standards (ASTM, ISO) and the laboratory methods prescribed within them. The "experts" would be the qualified laboratory personnel performing these physical and chemical tests. Their specific qualification details are not provided in this regulatory summary but are presumed to be in compliance with good laboratory practices.

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

Not applicable. This is not a study involving human interpretation or subjective judgment that would require an adjudication process. The tests are objective measurements against defined physical and chemical 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 document is for a physical medical device (examination gloves), not an AI diagnostic algorithm. Clinical testing was explicitly stated as "not needed for this device."

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" here is defined by established consensus standards from organizations like ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards specify physical properties, test methods, and acceptable limits for medical gloves. This includes:

• ASTM D5250 (Standard specification for poly (vinyl chloride) 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)
• 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)

8. The sample size for the training set

Not applicable. This is for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" for this type of submission. The manufacturing process itself (Good Manufacturing Practices) would ensure consistent product quality, but there's no data training aspect.

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

Not applicable, as there is no training set for a physical device.

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