Search Results

The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; 5-Fluorouracil, Cisplatin, Etoposide, Vincristine Sulfate and Paclitaxel] WARNING: DO NOT USE GLOVES WITH CARMUSTINE OR THIO-TEPA

Powder Free Blue Nitrile Examination Gloves, Sterile with Chemotherapy Claim meet all the requirements of ASTM standard D6978-05, D5712-0562 and FDA 21 CFR 880.6250.

This document describes the acceptance criteria and performance of "Powder Free Blue Nitrile Examination Gloves, Sterile with Chemotherapy Claim." This device is a medical glove, and the study focuses on its physical properties, biocompatibility, watertightness, sterility, and critically, its resistance to permeation by chemotherapy drugs.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Detailed Breakthrough Detection Time for Chemotherapy Drugs (per ASTM D6978-05):

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

The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for dimensions, thickness, or chemotherapy drug permeation). It references compliance with ASTM standards, which typically define minimum sample sizes for such tests.
Data provenance is not explicitly stated as country of origin, but the submitting company is WRP Asia Pacific Sdn Bhd, located in Malaysia, suggesting the testing might have been conducted there or through certified labs globally. The data appears to be from retrospective testing conducted to demonstrate compliance with established standards.

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

This type of device (patient examination glove) does not typically involve human experts to establish "ground truth" in the way a diagnostic imaging AI would. The "ground truth" for the performance tests (like dimensions, physical properties, watertightness, chemical permeation, and sterility) is established by the specified ASTM (American Society for Testing and Materials) and ISO standards. These standards define the test protocols and acceptance criteria, and the results are obtained through objective physical and chemical measurements rather than subjective human interpretation. Therefore, there are no "experts" in the traditional sense of clinical specialists establishing ground truth; rather, qualified laboratory technicians conduct the tests according to the standard protocols.

4. Adjudication method for the test set

Not applicable. As noted above, the "ground truth" is determined by objective measurements against established standards, not by expert consensus or adjudication of subjective interpretations.

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 not a diagnostic AI device requiring human reader performance studies. It is a physical medical device (glove) whose performance is evaluated through objective physical and chemical testing.

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

Not applicable. This is not an AI algorithm.

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

The ground truth used for all performance characteristics is defined by objective measurements and test methods specified in the referenced ASTM and ISO standards. For example:

• Physical properties (Dimensions, Thickness, Physical Properties): Measured values compared against specified ranges in ASTM D6319-00a.
• Powder Free: Gravimetric measurement (≤ 2 mg/glove by ASTM D6124-01).
• Biocompatibility: In vitro or in vivo tests (e.g., guinea pig maximization test for sensitization) as per ASTM F-720-81, with "Passes" indicating lack of irritation/sensitization.
• Watertight: Visual inspection for leaks after filling with water as per ASTM D5151-06 (1000ml), often with an AQL (Acceptable Quality Limit) specified.
• Resistance to permeation by Chemotherapy Drugs: Breakthrough time measured using analytical methods (e.g., gas chromatography, liquid chromatography) as per ASTM D6978-05.
• Sterility: Dose validation report according to ANSI/AAMI/ISO 11137, confirming a Sterility Assurance Level (SAL) of 10-6.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The "device performance" is based on testing batches of manufactured gloves against predefined standards.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device