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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019)

Powder Free Polyurethane Examination Gloves, Blue color, tested for use with Chemotherapy Drugs are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L, XL and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).

The provided text describes the acceptance criteria and performance data for "Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs." This is a medical device, and the data pertains to its physical properties, biocompatibility, and resistance to chemotherapy drugs, all tested against established ASTM and ISO standards.

It is important to note that this device is a physical product (gloves) and not an AI/ML powered medical device. Therefore, many of the requested criteria (e.g., sample size for AI test/training sets, data provenance, expert adjudication, MRMC studies) are not applicable in this context. The information provided focuses on material science and medical device performance standards for physical safety and efficacy.

Here's a breakdown of the applicable information based on your request, along with an explanation for why certain criteria are not relevant:

Acceptance Criteria and Device Performance for "Powder Free Polyurethane Examination Gloves"

This device is not an AI/ML powered medical device. The acceptance criteria and performance are established through adherence to recognized international standards for medical examination gloves and specific testing for chemotherapy drug permeation.

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug Permeation Data (from ASTM D6978-05 (2019) testing):

• Warning: Do not use with Carmustine or Thiotepa due to extremely low permeation times.

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

• Sample Size: The document does not explicitly state the sample size (number of gloves or test replicates) for each specific test (e.g., physical dimensions, watertightness, chemotherapy permeation). However, testing is performed in accordance with the methodologies described in the cited ASTM and ISO standards, which will specify appropriate sample sizes for validation.
• Data Provenance: The document indicates the manufacturer is "Grand Work Plastic Products Co., Ltd" with a China address (Donggao Industrial Zone, Zanhuang, Hebei, 050000, China). This implies the testing would have been conducted or overseen by the manufacturer, likely at their facilities or accredited contract labs. The data is retrospective, as it was collected as part of the premarket notification (510(k)) submission.

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

• Not Applicable. For a physical device like examination gloves, "ground truth" is established through standardized laboratory testing protocols (e.g., tensile strength, leak tests, chemical permeation) as defined by ASTM and ISO organizations. These tests yield objective, quantitative measurements rather than subjective expert interpretations. Therefore, there are no "experts" in the sense of human readers/annotators establishing ground truth for a test set. The "experts" involved are the scientists and engineers who developed and validated these international testing standards.

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

• Not Applicable. Adjudication methods are relevant for studies where subjective human interpretation or labeling is involved (e.g., medical image analysis, clinical assessments). For physical product testing, the results are typically quantitative and objective, and thus do not require an adjudication process.

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 physical medical device (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Ground Truth: The "ground truth" for this device's performance is established by the objective, quantitative measurements obtained through adherence to the specified ASTM and ISO standard test methods. These standards define the accepted methodologies for determining physical properties, biocompatibility, and chemical resistance. For example:
  • Physical properties (length, thickness, tensile strength, elongation): Measured directly using calibrated equipment according to ASTM D6319-19 and ASTM D412-16.
  • Watertightness: Determined by the "water leak test" (ASTM D5151-19) which is a pass/fail visual inspection after standardized water filling.
  • Powder Residue: Measured gravimetrically according to ASTM D6124-06.
  • Chemotherapy Drug Permeation (BDT): Determined by measuring the time it takes for a chemical to permeate the glove material using a detector, as per ASTM D6978-05.
  • Biocompatibility (Irritation, Sensitization, Cytotoxicity, Systemic Toxicity): Assessed through laboratory tests (e.g., cell cultures, animal models) conducted according to ISO 10993 standards, yielding specific biological responses.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device.

Summary of Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a compilation of non-clinical performance tests conducted in accordance with well-established international standards (ASTM and ISO). These tests systematically evaluate the physical properties, chemical resistance, and biocompatibility of the gloves.

The "Pass" results for each test (as shown in the table under "Non-Clinical Performance Data") demonstrate that the "Powder Free Polyurethane Examination Gloves" meet the pre-defined acceptance criteria for a Class I medical device of this type. The specifics of the testing (e.g., detailed methodology, equipment calibration, environmental controls) would be documented in the full test reports that support the 510(k) submission. The FDA's clearance (K222892) indicates that they have reviewed this data and found it sufficient to demonstrate substantial equivalence to legally marketed predicate devices, confirming the device's safety and effectiveness for its intended use. The critical warning regarding Carmustine and Thiotepa permeation times is a direct outcome of these tests and is vital for safe labeling and use.

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