(258 days)
The Palm-pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs.
The following Chemotherapy drugs have been tested for use with these gloves in accordance with ASTM D6978-05:
| Chemotherapy drug (concentration) | Breakthrough Detection Time |
|---|---|
| Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes |
| *Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes |
| Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes |
| Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes |
| Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes |
| Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes |
| Etoposide (20,000 ppm) | No breakthrough up to 240 minutes |
| Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes |
| Thiotepa (10,000 ppm) | Breakthrough at 181.3 minutes |
*Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 30.6 minutes.
The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs are patient examination gloves that worn by an examiner to prevent contamination between the patient and examiner. The gloves are suitable for use with Chemotherapy drugs, are ambidextrous and green in color. The gloves are supplied non-sterile, in boxes of 100 (measured by weight), intended for single use and are disposable.
This document describes a 510(k) premarket notification for "Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs" (K161929). The core of the submission is to demonstrate substantial equivalence to a predicate device (K141982).
This document does not describe a study involving an AI/ML device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Instead, it focuses on the equivalence of physical properties and performance to a predicate device, specifically regarding glove integrity and resistance to chemotherapy drugs.
Therefore, many of the requested criteria regarding AI/ML device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, effect size of human reader improvement with AI, standalone performance, training set ground truth establishment) are not applicable to this type of medical device submission.
However, I can extract the acceptance criteria and reported "performance" based on the product's physical and chemical resistance properties as presented in the document.
Acceptance Criteria and Reported Device Performance (as applicable to a physical medical device)
The device, Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs, is assessed against standards and a predicate device. The "acceptance criteria" can be inferred from the "Meets requirements" or "Passes" statements for various tests, and in the case of chemotherapy drug permeation, the reported breakthrough times, particularly as compared to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Inferred from documentation) | Reported Device Performance (Palm-Pro Nitrile Glove) | Comparison to Predicate (K141982) |
|---|---|---|---|
| Biocompatibility (ISO 10993-10) | Non-irritating (for primary skin irritation) | Non-irritating | Met/Comparable |
| Non-sensitizing (for dermal sensitization) | Non-sensitizing | Met/Comparable | |
| Dimensions (ASTM D6319-10) | Overall length: 240mm min. | Overall length: 240mm min. | Same |
| Finger Thickness: Within 0.07-0.10mm range of predicate | Finger: 0.09 – 0.10mm | Similar (within predicate bounds) | |
| Palm Thickness: Within 0.07-0.09mm range of predicate | Palm: 0.07 – 0.08mm | Similar (within predicate bounds) | |
| Water Leak Test (ASTM D6319-10) | AQL level met | PASS (AQL level met) | Same ("Passes" for predicate) |
| Tensile Strength & Ultimate Elongation (ASTM D6319-10) | Meets requirements (pre-aging and after aging) | PASS | Same ("Meets requirements" for predicate) |
| Powder Content (ASTM D6319-10) | Residual powder content determined per glove, meets requirements (i.e., "Passes") | PASS | Same ("Passes" for predicate) |
| Freedom from holes | Passes | Passes | Same |
| Chemotherapy Drug Permeation (ASTM D6978-05) | |||
| - Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Carmustine (BCNU) (3,300 ppm) | Breakthrough at or above 15 minutes (predicate's breakthrough time) | Breakthrough at 30.6 minutes | Higher breakthrough time for subject device (Better than predicate) |
| - Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Etoposide (20,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes (comparable to predicate) | No breakthrough up to 240 minutes | Comparable (>240 min for predicate) |
| - Thiotepa (10,000 ppm) | Breakthrough at or above 2.0 minutes (predicate's breakthrough time) | Breakthrough at 181.3 minutes | Higher breakthrough time for subject device (Better than predicate) |
Study Details (as applicable to a physical device)
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Sample size used for the test set and the data provenance:
- The document states that the tests were performed "in accordance with ASTM D6319-10" and "ASTM D6978-05." These ASTM (American Society for Testing and Materials) standards typically specify the number of samples required for various physical and chemical tests (e.g., minimum number of gloves for water leak, dimensions, or permeation testing). However, the * exact sample sizes used for each test* are not explicitly stated in this summary document.
- Data Provenance: The manufacturer is Dipped Products (Thailand) Ltd., located in Thailand. The testing was conducted as "non-clinical performance data" to support the 510(k) submission, implying it was conducted as part of the device development and premarket evaluation process. It's prospective for the purpose of this submission (i.e., tests were run to demonstrate current performance for this specific device).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This criterion is not applicable as this is a physical medical device (glove) that undergoes standardized physical and chemical testing, not an AI/ML device requiring human expert annotation for "ground truth" establishment in a diagnostic context. The "ground truth" for these tests is defined by the objective measurements and pass/fail criteria of the ASTM standards.
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Adjudication method for the test set:
- This criterion is not applicable. Adjudication (e.g., 2+1, 3+1) is a process used in medical image interpretation studies, typically for AI/ML evaluation, where multiple human readers disagree, and a tie-breaker or consensus is needed. For physical device performance tests, the results are quantitative measurements or pass/fail outcomes based on pre-defined test methodologies, not subjective interpretations requiring adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic AI/ML devices where human readers (e.g., radiologists) interact with or without AI assistance. This document pertains to a physical examination glove.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This criterion is not applicable. This is a physical device, not an algorithm. The performance described is the inherent physical and chemical resistance of the glove itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this physical medical device, the "ground truth" is established by the standardized test methods and specifications outlined in ASTM International standards (ASTM D6319-10 for physical properties and ASTM D6978-05 for chemotherapy drug permeation). These standards define how to measure properties like dimensions, tensile strength, freedom from holes, and breakthrough times, establishing the objective and reproducible basis for performance evaluation.
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The sample size for the training set:
- This criterion is not applicable. This is a physical glove, not an AI/ML model that undergoes "training" on a dataset.
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How the ground truth for the training set was established:
- This criterion is not applicable for the same reason as point 8.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.