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Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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.

Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nitrile Powder Free Patient Examination Gloves.

It's important to note that this document is a 510(k) summary for a Class I medical device (gloves). For such devices, clinical studies are typically not required, and the focus is on meeting established performance standards (ASTM, FDA regulations). Therefore, many of the typical AI/software device evaluation criteria (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies) are not applicable or present in this submission.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document does not specify explicit sample sizes for the individual tests (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). These are typically quality control tests performed on batches of gloves according to the relevant ASTM or ISO standards.
   • Data provenance is not explicitly stated, but given the manufacturer is based in China, it is highly likely the testing was conducted there. The testing is prospective in the sense that it evaluates the manufactured product against predefined standards.

2. 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 criterion is not applicable. The "ground truth" for glove performance involves objective measurements and adherence to specified physical and chemical properties defined by standards (ASTM, ISO, CFR). It does not rely on expert interpretation in the same way clinical diagnostic devices do. Biocompatibility tests are conducted by specialized laboratories.

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

   • Not applicable. Performance is determined by objective measurements against numerical or qualitative pass/fail criteria defined in the standards, not by expert adjudication.

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 physical examination glove, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

   • Not applicable. This is a physical product, not an algorithm or software.

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

   • The "ground truth" for this device's performance is based on objective measurements against established engineering and material science standards (ASTM D6139-05, ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, ISO10993-10). This includes dimensional accuracy, physical strength, integrity (freedom from pinholes), chemical residue, and biological reaction (irritation, sensitization).

7. The sample size for the training set

   • Not applicable. This concept pertains to machine learning models, which are not relevant for this device.

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

   • Not applicable, as there is no training set in the context of this device.

Summary of the Study:

The "study" demonstrating the device meets acceptance criteria is primarily a series of non-clinical bench and lab tests against well-established international and national standards. The manufacturer conducted these tests and reported that their Nitrile Powder Free Patient Examination Gloves "Meets" or "Passes" all specified criteria from ASTM D 6139-05, 21 CFR 800.20, ASTM D 5250-06, ASTM D6124-06, and ISO10993-10. These tests cover the critical performance aspects for patient examination gloves, including their physical integrity, durability, and biocompatibility, ensuring they are safe and effective for their intended medical purpose of preventing contamination. No clinical data was required or submitted, as is typical for this type of device.

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