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Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Permeation

• The following chemicals have been tested with these gloves

• Please note that the following drugs have extremely low permeation times:

Carmustine (BCNU): 10.1 minutes and Thiotepa: 20.2 minutes

Nitrile Blue Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs
Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

This document describes the FDA's substantial equivalence determination for Nitrile Blue Powder Free Examination Gloves. It focuses on their safety and effectiveness, particularly when exposed to chemotherapy drugs, based on performance criteria.

Here's an analysis of the provided information, framed by your request for acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for permeation by chemotherapy drugs are not explicitly stated as numerical targets in the document. However, they are implied by the testing methodology and the presentation of "Breakthrough Detection Time in Minutes." The general acceptance would be to demonstrate a reasonable barrier against these drugs, with the specific times providing the performance metrics.

Note: The document highlights that Carmustine and Thiotepa had "extremely low permeation times" compared to others, indicating these might be areas of concern if specific minimum times were regulatory requirements.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the sample size (number of gloves or tests) used for the chemotherapy drug permeation study. The table presents drug-specific results, but not the number of replicates or individual tests contributing to those results.
• Data Provenance: The study was conducted "as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard is a highly detailed, globally recognized protocol for testing these products, ensuring reproducibility and reliability of the data. The country of origin of the data is not specified beyond the Malaysian company (GMP Medicare SDN. BHD.) submitting the device. It is a prospective study as tests were conducted to specific ASTM standard.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and therefore not provided in the document. The "ground truth" for this device's performance is established by the results of physical and chemical testing (specifically, permeation testing against a standardized protocol), not by expert consensus or interpretation of images/data. The ASTM D6978-05 standard itself defines the methodology for determining this ground truth (breakthrough time).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical or diagnostic studies where expert opinions or interpretations are being harmonized. For material performance testing, the results are derived directly from the test procedure according to the ASTM standard, not from human adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a medical glove, and its performance for chemotherapy drug permeation is assessed through laboratory material testing, not through human reader interpretation of cases or clinical scenarios. Therefore, an MRMC study and the concept of "improving human readers with AI" are irrelevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI/algorithm-based device. Its performance is purely based on the physical barrier properties of the glove material when exposed to specific chemicals.

7. Type of Ground Truth Used

The ground truth used is based on physical and chemical testing results derived from a standardized protocol: ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This standard uses instrumental analysis to detect when a chemotherapy drug permeates through the glove material.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the context of developing an algorithm. The testing described is for performance validation, not for training a model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm. The "truth" for the product's performance is established through direct, standardized laboratory testing as outlined in point 7.

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