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

The subject device is a patient examination glove made of synthetic nitrile latex compound. It is Non-Sterile, Powder free and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-11.

The provided text describes Shandong Intco Medical Products Co, Ltd.'s Basic Synguard Nitrile Exam Gloves. This is a medical device submission, and the acceptance criteria and study described relate to the physical and biocompatibility performance of these gloves.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Freedom from holes: 315 gloves were tested.
• Other physical properties (Dimensions, Physical Properties, Residual Powder): The document does not explicitly state the sample size for each test, but it references ASTM D6319-19, ASTM D6124-06, and ASTM D5151-19, which would define the sampling plans. For "Freedom from holes," the sample size of 315 and AQL 2.5 is typical for ASTM D5151.
• Biocompatibility: The sample sizes for the ISO 10993 tests are not explicitly stated in this document but are defined by the respective ISO standards.
• Data Provenance: The studies were conducted by Shandong Intco Medical Products Co., Ltd. (China) for their device. The nature of these tests (physical and biocompatibility testing on manufactured products) categorizes them as prospective performance evaluations of the device itself.

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

This section is not applicable as the device is a medical glove, and the "ground truth" is established through standardized laboratory testing against objective criteria (e.g., tensile strength, dimensions, presence of holes, chemical residues, biological reactions in test models) as defined by ASTM and ISO standards, not expert interpretation of cases.

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

This section is not applicable as the device is a medical glove, and the performance is measured directly by physical and chemical tests, not through 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

This section is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a medical glove, not an algorithm.

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

The "ground truth" for the device's performance is established by:

• Pre-defined physical and chemical specifications from ASTM standards (e.g., minimum tensile strength, maximum residual powder, dimensional tolerances).
• Biological responses (e.g., no irritation, no sensitization, no systemic toxicity) in animal or in vitro test models, as defined by ISO 10993 standards.

8. The sample size for the training set

This section is not applicable. The device is a medical glove, and this is not a machine learning model requiring a training set.

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

This section is not applicable.

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