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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile.

The following chemotherapy drugs have been tested on the glove:

*Please note that the following drugs have low permeation time.

1. Carmustine
2. ThioTepa

Warning: Do not use with Carmustine & ThioTepa

The proposed Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Polychloroprene. The gloves are not made with natural rubber latex. General specifications of the glove are as below:

1. Overall Length: 240 mm minimum
2. Width: 95 ± 5 mm minimum (for medium glove)
3. Palm Thickness: 0.05 mm minimum
4. Finger Thickness: 0.05 mm minimum
5. Cuff Thickness: 0.05 mm minimum
6. Tensile Strength
   • a. Before Aging: 14 MPa minimum
   • b. After Aging: 14 MPa minimum
7. Ultimate Elongation
   • a. Before Aging: 500 % minimum
   • b. After Aging: 400 % minimum
8. Pinhole AQL: 2.5

The provided FDA 510(k) clearance letter and associated documentation pertain to a Powder-Free Polychloroprene Examination Glove. This is a physical medical device, not an AI/software device. Therefore, the questions related to AI/software performance criteria (such as multi-reader multi-case studies, human-in-the-loop performance, training/test set ground truth, and expert adjudication) are not applicable to this documentation.

The acceptance criteria and performance data provided in the document relate to the physical and chemical properties of the gloves, and their resistance to permeation by chemotherapy drugs and fentanyl.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text, focusing on the relevant physical device aspects:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance

*Note: The document explicitly warns that Carmustine and ThioTepa have low permeation times and should not be used with the glove. This is a crucial labeling instruction based on the test results.

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

• The document does not explicitly state the specific sample sizes used for each physical, chemical, and permeation test. However, tests are typically performed on a statistically relevant number of samples to ensure representativeness and robust results according to the specified ASTM and ISO standards.
• Data Provenance: The tests appear to have been conducted by Encompass Industries Sdn. Bhd. or a contracted lab on their behalf. The company is located in Kertih Bio-Polymer Park, Kemaman, Terengganu, Malaysia. The data is prospective in the sense that the tests were specifically performed on the proposed device for the purpose of this 510(k) submission.

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 as the document describes a physical medical device (examination glove) and its material/permeation performance, not a software/AI device that requires expert human interpretation of data for ground truth establishment. The "ground truth" for these tests is based on objective, standardized laboratory measurements (e.g., precise measurements of length, thickness, tensile strength; chemical analysis for powder residue; standardized biological assays for biocompatibility; and analytical chemistry for drug permeation breakthrough times).

4. Adjudication Method for the Test Set

• This question is not applicable for the same reason as point 3. Testing of physical device characteristics and chemical permeation is typically performed according to established laboratory protocols with quantitative, measurable endpoints, not through a process of expert adjudication.

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

• This question is not applicable as the document describes a physical medical device (examination glove), not an AI-assisted diagnostic or therapeutic tool.

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

• This question is not applicable as the document describes a physical medical device (examination glove), not an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance of the examination gloves is based on objective, standardized laboratory measurements and adherence to established international and national standards (e.g., ASTM D6977-19, ASTM D6319-19, ASTM D5151-19, ASTM D412-16, ASTM D573, ASTM D6124-06, ASTM D6978-05, ISO 10993-10, ISO 10993-11, 21 CFR 800.20).
  • Examples include:
    • Physical measurements: Direct measurement of glove dimensions (length, width, thickness).
    • Mechanical properties: Tensile strength and elongation determined by standard material testing methods.
    • Integrity: Freedom from holes determined by water leak testing (ASTM D5151-19).
    • Chemical analysis: Measurement of residual powder.
    • Biocompatibility: In-vivo (skin irritation, sensitization, acute systemic toxicity) tests using animal models, following ISO standards.
    • Permeation: Breakthrough detection time of specific chemotherapy drugs and fentanyl using analytical methods (ASTM D6978-05).

8. The Sample Size for the Training Set

• This question is not applicable as the document describes a physical medical device, which does not involve a "training set" in the context of machine learning or AI.

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

• This question is not applicable for the same reason as point 8.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.

The proposed Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. The patient examination gloves are not made with natural rubber latex.

The provided document describes the acceptance criteria and study results for Powder-Free Nitrile Examination Gloves.

Here's the requested information:

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 specific sample sizes used for each test (e.g., how many gloves were tested for dimensions, holes, or chemical permeation). It lists "Device Performance (Minimum)" in tables, implying that measurements were taken across a sample.

The data provenance is not explicitly mentioned (e.g., country of origin for the testing or if it was retrospective/prospective). However, the submitter's address is Malaysia: "Lot 18256, Kawasan Perindustrian Lot Q, Kertih Bio-Polymer Park, 24300 Kemaman, Terengganu, Malaysia." The testing standards cited are international (ASTM, ISO).

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

Not applicable. This device is a medical glove, and the "ground truth" for its performance is established through objective, standardized physical and chemical permeation tests, and biocompatibility studies, not through expert consensus or interpretation of medical images/conditions. The performance is measured against established scientific and engineering standards (ASTM and ISO).

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements against defined standards, not subjective interpretations requiring adjudication.

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 an AI-powered diagnostic or interpretive device.

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

Not applicable. This is a physical medical device (glove), not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the performance of the medical gloves is established through:

• Standardized Physical and Mechanical Testing: Against ASTM D6319-19 requirements for dimensions, tensile strength, elongation, and residual powder.
• Permeation Testing: Against ASTM D6978-05 for chemotherapy drugs.
• Biocompatibility Testing: Against ISO 10993-5 (In Vitro Cytotoxicity - although the proposed device showed potential cytotoxicity, it was then deemed safe by the Acute Systemic Toxicity test), ISO 10993-10 for skin irritation and sensitization, and ISO 10993-11 for acute systemic toxicity.

These are all objective, laboratory-based measurement criteria rather than expert consensus, pathology, or outcomes data in a clinical setting.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for a physical device.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

In addition, the glove was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

The following chemotherapy drugs have been tested with the white glove:
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Dacarbazine (DTIC) 10.0mg/ml > 240
Carmustine (BCNU) 3.3mg/ml 11.2
Thiotepa (THT) 10.0mg/ml 25.2

*Please note that the following 2 drugs have extremely low permeation times:

1. Carmustine: 11.2 minutes
2. Thiotepa: 25.2 minutes

Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).

The following chemotherapy drugs have been tested with the blue glove:
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Dacarbazine (DTIC) 10.0mg/ml > 240
Carmustine (BCNU) 3.3mg/ml 10.7
Thiotepa (THT) 10.0mg/ml 21.5

*Please note that the following 2 drugs have extremely low permeation times:

1. Carmustine: 10.7 minutes
2. Thiotepa: 21.5 minutes

Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).

The following chemotherapy drugs have been tested with the black glove:
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Dacarbazine (DTIC) 10.0mg/ml > 240
Carmustine (BCNU) 3.3mg/ml 11.0
Thiotepa (THT) 10.0mg/ml 11.1

*Please note that the following 2 drugs have extremely low permeation times:

1. Carmustine: 11.0 minutes
2. Thiotepa: 11.1 minutes

Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).

Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs

This document is a 510(k) premarket notification from the FDA regarding "Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs." It does not describe an AI/ML powered device, and therefore the acceptance criteria and study information requested in the prompt are not applicable.

The document provides information on the breakthrough detection times of various chemotherapy drugs when tested with the gloves, as per ASTM D6978-05. It clearly states the permeation times for different chemotherapy drugs and warns against the use of these gloves with Carmustine and Thiotepa due to their extremely low permeation times.

Since the prompt asks for information pertaining to an AI/ML powered device, and this document describes a physical medical device (examination gloves), a direct answer to the prompt's specific questions about AI/ML device performance, ground truth establishment, expert adjudication, and MRMC studies cannot be provided from the given text.

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