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Nitrile Powder Free 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.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile 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. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document describes a 510(k) premarket notification for "Nitrile Powder Free Patient Examination Gloves, Blue Color," which is a Class I medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than describing a study to prove performance against acceptance criteria for an AI/ML powered device.

Therefore, many of the requested fields are not applicable to this document. I will extract the available information and indicate where information is not present or not relevant to an AI/ML context.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of an AI/ML algorithm. The performance data presented (e.g., dimensions, physical properties, biocompatibility) are based on testing a sample of the manufactured gloves to ensure they meet the established standards. The size of these samples is not explicitly stated in the provided text. The data provenance is implied to be from the manufacturer's testing, Haining Medical Products Co., Ltd., which is located in China. The testing is assumed to be prospective relative to the 510(k) submission.

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

This information is not applicable. The device is a patient examination glove, not an AI/ML diagnostic tool requiring expert ground truth for interpretation. Performance is assessed against international standards and regulations (e.g., ASTM, ISO, CFR).

4. Adjudication method for the test set

This information is not applicable. There is no expert review or adjudication process described for the performance testing of these gloves.

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. The device is a physical medical glove and does not involve AI/ML or human readers.

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

This information is not applicable. The device is a physical medical glove and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for the glove's performance is based on established international standards and regulatory requirements for medical gloves, such as ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, 21 CFR 800.20, and ISO 10993-10. These standards define the acceptable physical, mechanical, and biological properties.

8. The sample size for the training set

This information is not applicable. The device is a physical medical glove and does not involve an AI/ML training set.

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

This information is not applicable. The device is a physical medical glove and does not involve an AI/ML training set or its associated ground truth establishment.

Summary of the Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical performance testing conducted by Haining Medical Products Co., Ltd. (the manufacturer) to demonstrate that the "Nitrile Powder Free Patient Examination Gloves, Blue Color" meet the requirements outlined in various ASTM standards (D6319-10, D6124-06, D5151-06), 21 CFR 800.20, and ISO 10993-10 (for biocompatibility). These standards set the acceptance criteria for properties like dimensions, physical strength (tensile strength, elongation), freedom from pinholes (waterleak test), powder residue, and biocompatibility (skin irritation and sensitization).

The study involved testing samples of the manufactured gloves against these specified standards. For instance, dimensions (length, width, thickness), physical properties (elongation, tensile strength), and powder residue were measured and found to "Meet" or exceed the requirements of the ASTM standards. Freedom from pinholes was assessed against 21 CFR 800.20 and ASTM D5151-06 with an Acceptable Quality Level (AQL) of 2.5% for holes. Biocompatibility testing (Primary Skin Irritation in rabbits and Dermal Sensitization in guinea pigs) was performed according to ISO 10993-10, and the gloves "Passed," demonstrating they were not irritants or sensitizers.

The results of these tests, as summarized in the table and the "6.0 Summary of the Technological Characteristics of the Device" and "7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data" sections, directly demonstrate that the device performs according to the established acceptance criteria. No clinical data was deemed necessary for this type of device according to the document. The overall conclusion is that the device is "as safe, as effective, and performs as well as the predicate device," thereby establishing substantial equivalence.

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