Search Results

A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The list of Chemotherapy Drugs tested (with breakthrough times) is as below:

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

This document is a 510(k) premarket notification letter for a Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs. It explicitly states that the device is a "non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."

The key performance aspect highlighted by this document is the glove's resistance to permeation by chemotherapy drugs. The study mentioned is in accordance with ASTM D6978-05, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Here's the breakdown of the requested information based on the provided text, recognizing that this document is an FDA clearance letter and not a full study report, so some details might be absent:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for resistance to chemotherapy drugs are implied by the standard ASTM D6978-05. While the standard itself sets the methodology, typical acceptance criteria for medical gloves exposed to chemotherapy drugs aim for a breakthrough time that is as long as possible, usually exceeding the expected duration of contact or handling. The reported performance is the "breakthrough time" for each drug.

Note: The ">240 minutes" indicates that no breakthrough was detected within the 240-minute test period, which is a very positive result. The shorter times for Carmustine and Thiotepa indicate that these drugs permeated the glove more quickly than others, but the specific acceptance threshold (e.g., minimum acceptable breakthrough time for each drug) is not stated in this document.

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

The document does not explicitly state the sample size (number of gloves or test replicates) used for testing each chemotherapy drug. It only refers to the general standard, ASTM D6978-05. The data provenance (country of origin, retrospective/prospective) is also not stated. This information would typically be in the full test report, not the FDA clearance letter.

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

This question is not applicable to this type of device and study. The "ground truth" for glove permeation is established through a standardized laboratory test (ASTM D6978-05) measuring physical properties, not through expert consensus or interpretation of clinical data. Therefore, no experts in the sense of medical professionals establishing a diagnosis were involved in establishing "ground truth" for this performance characteristic.

4. Adjudication method for the test set

Not applicable. This is a laboratory test measuring a physical property (breakthrough time) using a standardized methodology, not a clinical study requiring adjudication of expert opinions.

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 physical barrier (glove), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its performance evaluation.

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

Not applicable. This device is a physical barrier (glove), not an algorithm or AI system.

7. The type of ground truth used

The ground truth is established by a standardized laboratory measurement according to ASTM D6978-05. This standard describes the specific method for determining the breakthrough time of chemotherapy drugs through medical gloves, using analytical detection methods (e.g., spectrophotometry, chromatography) to identify the permeation of the drug through the glove material.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model. There is no concept of a "training set" for its development or testing in the context of this document.

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

Not applicable (as above).

Ask a specific question about this device

Ask a specific question about this device