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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 Tested chemotherapy drugs are as follows [Cyclophosphamide, drugs. Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE

Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein} meet all the requirements of ASTM standard D6978-05, D5712-054 and FDA 21 CFR 880.6250.

The device, "Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein)," demonstrated compliance through a series of non-clinical performance studies. The studies assessed the gloves against various ASTM standards and internal performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., dimensions, physical properties, thickness, powder free, protein level, biocompatibility, watertight, or chemotherapy drug permeation). It references ASTM standards for these tests, which typically specify sample size requirements.

The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer, WRP Asia Pacific Sdn Bhd, in Malaysia. The studies were non-clinical, and it is implied they were conducted in-house or by accredited labs following the referenced ASTM standards. The data is retrospective in the sense that results from these tests are being presented for regulatory review.

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

N/A. This is a non-clinical device (gloves) and the "ground truth" is established by adherence to recognized ASTM performance standards and laboratory test results, not by expert medical opinion or diagnostic accuracy.

4. Adjudication Method for the Test Set

N/A. This is a non-clinical device. Test results are objective measurements against defined standard criteria.

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

N/A. This is a non-clinical device (examination gloves). MRMC studies are typically performed for diagnostic or AI-assisted interpretation devices where human interpretation is involved.

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

N/A. This device is not an algorithm or AI system. Its performance is assessed through physical and chemical testing.

7. Type of Ground Truth Used

The "ground truth" for this device is established by:

• ASTM Standard Specifications: Adherence to established and recognized American Society for Testing and Materials (ASTM) standards for physical properties, dimensions, thickness, powder content, protein levels, and watertight integrity.
• Laboratory Test Results: Objective measurements and observations from tests conducted according to these ASTM standards (e.g., protein content measurement, permeation studies for chemotherapy drugs, biocompatibility tests).

8. Sample Size for the Training Set

N/A. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

N/A. As there is no training set for this type of device, this question is not applicable.

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