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A single use, disposable, powder-free examination glove, intended for medical purposes, that is worn on the examiner's hands to prevent contamination between the patient and examiner.

White colored nitrile, chlorinated, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is an FDA 510(k) clearance letter for a "Powder Free Nitrile Patient Examination Glove With Colloidal USP a Skin Protectant Drug." This type of document declares a device substantially equivalent to a predicate device, allowing it to be marketed.

Crucially, this letter does not contain detailed information about acceptance criteria for specific performance metrics, nor does it describe a study proving the device meets particular criteria in the way a clinical trial or a formal performance study report would.

The FDA's 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This often involves comparing device characteristics (e.g., materials, performance standards) and showing that any differences do not raise new questions of safety or effectiveness.

However, based on the information provided, we can infer some aspects relevant to a hypothetical acceptance criteria and study, particularly regarding the glove's physical performance for medical application:

Inferred Information based on the provided document:

The document states: "Device Description: White colored nitrile, chlorinated, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application."

This sentence is the key to understanding the "acceptance criteria" and the "study" in this context.

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

Since the document explicitly states the device "meets all of the requirements of ASTM D 6319-10," the acceptance criteria are those defined in that ASTM standard. Without access to ASTM D 6319-10, we cannot provide the full table, but common criteria for examination gloves include:

Note: The exact numerical values for these criteria would be detailed within the ASTM D 6319-10 standard. The device "meets" these, implying the test results fell within the acceptable ranges specified by the standard.

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

The document does not specify the sample size for testing against ASTM D 6319-10. ASTM standards typically define sampling plans (e.g., AQL levels for defect testing).

• Data provenance: Not specified, but generally, manufacturers perform these tests at their own facilities or accredited labs. It would be a prospective test conducted on representative samples of the manufactured gloves. Country of origin for the data is not mentioned.

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

Not applicable in this context. For physical performance tests of examination gloves, ground truth is established by objective measurements based on the ASTM standard's methodology. There are no "experts" in the sense of clinicians or radiologists establishing a diagnostic ground truth. Lab technicians trained in material testing and quality control would perform the tests.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements, not subjective evaluations 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 a medical device clearance for an examination glove, not an AI or diagnostic imaging device.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

For the physical performance aspects (freedom from holes, dimensions, tensile strength, elongation), the "ground truth" is derived from objective measurements of the manufactured gloves against the scientifically established and consensus-driven parameters defined in the ASTM D 6319-10 standard.

8. The sample size for the training set

Not applicable. There is no AI model or training set involved for this type of device. Manufacturing processes are optimized, but this isn't "training" in the machine learning sense.

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

Not applicable, as there is no training set in the AI sense.

Summary of what is specifically addressed in the document:

• The device is a "Powder Free Nitrile Patient Examination Glove With Colloidal USP a Skin Protectant Drug."
• It is classified as Class I, product code LZA (Patient Examination Glove).
• It is intended for "medical purposes, that is worn on the examiner's hands to prevent contamination between the patient and examiner."
• It is for over-the-counter use (not prescription).
• The primary means of demonstrating performance for physical characteristics is adherence to ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application.

The FDA's decision of substantial equivalence is based on the manufacturer's demonstration that this device meets these established performance standards and is similar in intended use and technological characteristics to a predicate device. The letter itself doesn't contain the raw data or detailed study reports, but rather the regulatory conclusion based on the submission which would have included such data.

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