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Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device.

Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Carboxylated Nitrile. These gloves are blue in color and are powder free. The product is non-sterile, textured, ambidextrous with beaded cuff and single use only. Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) with sizes X-Small, Small, Medium, Large, X-Large and XX-Large are included in the submission.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for "Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)":

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

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

The document does not explicitly state the specific sample sizes used for each test. For many of the physical and chemical property tests (e.g., dimensions, tensile strength, freedom from holes, residual powder, chemotherapy drug permeation), the relevant ASTM standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05) would specify the required statistical sampling plans, but the summary document only provides the results.

Similarly, for biocompatibility tests (ISO 10993 series), the number of animals or cell cultures used is not detailed in this summary, but the standards themselves outline the required protocols.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that these are bench and lab tests for a premarket notification, it's highly probable that the tests were conducted prospectively by the manufacturer or a contracted testing laboratory to demonstrate compliance with the referenced standards.

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 and not provided since the studies performed are bench testing and biocompatibility testing against established international standards (ASTM and ISO). These types of tests do not typically involve human experts establishing a "ground truth" through interpretation, as would be the case for an AI diagnostic device. Instead, the "ground truth" is defined by the objective measurement parameters and criteria specified in the standard test methods themselves.

4. Adjudication method for the test set

Not applicable. As noted above, these are objective bench and lab tests against predefined specifications in standards. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1. The results are quantitative measurements or direct observations (e.g., passes/fails AQL).

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 device is a medical glove, not an AI diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was conducted or would be relevant.

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

Not applicable. This device is a medical glove, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluation of these nitrile examination gloves are the acceptance criteria defined by the relevant ASTM and ISO standards. These standards provide:

• Specific measurable thresholds (e.g., minimum length, minimum tensile strength, maximum residual powder).
• Defined test methods and methodologies (e.g., how to measure breakthrough time for chemotherapy drugs, how to assess irritation or sensitization).
• Statistical sampling plans (e.g., AQL for freedom from holes).

Compliance with these pre-defined, objective criteria from the standards constitutes the "ground truth" for the device's performance.

8. The sample size for the training set

Not applicable. This is a physical device (medical glove), not an AI model. Therefore, there is no "training set."

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

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

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