(14 days)
A powder-free 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| | Chemotherapy Drug and
Concentration | Minimum Breakthrough Detection Time
in Minutes, 0.01 µg/cm²/minute |
|----|----------------------------------------|-----------------------------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 0.61 |
| 2. | Cisplastin, (1.0mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | 5-Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10 mg/ml) | 10.6 |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes:
Carmustine (BCNU) (3.3 mg/ml) Thiotepa (10 mg/ml)
These patient examination gloves are formulated using Nitrile. They are a disposable device that is offered powder-free and non-sterile. Gloves are cornflower blue in color. Gloves are not made with natural rubber latex.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardinal Health Nitrile Cornflower Blue Powder-Free Examination Gloves, structured according to your request.
This document describes a medical device, specifically examination gloves, and presents testing results, rather than an AI/ML powered device. As such, several of your requested points (like "effect size of how much human readers improve with AI vs without AI assistance", training set size, etc.) are not applicable to this type of submission. I will address the relevant points and indicate when information is not applicable.
Acceptance Criteria and Device Performance for Nitrile Cornflower Blue Powder-Free Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Not explicitly stated, implied to be non-irritating for patient contact (standard practice for medical devices). | Gloves are non-irritating. |
| Guinea Pig Maximization (Sensitization Potential) | Not explicitly stated, implied to be non-sensitizing (standard practice for medical devices). | Gloves do not display any potential for sensitization. |
| Dimensions | ASTM D6319 | Gloves meet requirements of ASTM D6319. |
| Physical Characteristics | ASTM D6319 (for Nitrile examination gloves) | Gloves meet requirements for Nitrile examination gloves per D6319. |
| Freedom from Holes | 21 CFR 800.20 and ASTM D6319 | Gloves meet requirements of 21 CFR 800.20 and ASTM D6319. |
| Powder Residual | ASTM D6319 (for "Powder-Free" designation) using ASTM D6124 test method | Results generated values below 2mg of residual powder per glove, meeting powder level requirements for "Powder-Free" designation per ASTM D6319. |
| Chemotherapy Permeation (Minimum Breakthrough Time) | ASTM D6978-05 (0.01 µg/cm²/minute detection limit, max testing time 240 minutes) | Carmustine (BCNU) (3.3 mg/ml): 0.61 minutes |
| Cisplatin (1.0mg/ml): >240 minutes | ||
| Cyclophosphamide (20 mg/ml): >240 minutes | ||
| Doxorubicin HCl (2.0 mg/ml): >240 minutes | ||
| Etoposide (Toposar) (20 mg/ml): >240 minutes | ||
| 5-Fluorouracil (50 mg/ml): >240 minutes | ||
| Methotrexate (25 mg/ml): >240 minutes | ||
| Paclitaxel (Taxol) (6.0 mg/ml): >240 minutes | ||
| Thiotepa (10 mg/ml): 10.6 minutes |
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of gloves or test replicates) used for each individual test (e.g., skin irritation, dimensions, permeation). It states "Gloves meet requirements..." or "Results generated..." indicating that tests were performed to establish compliance.
- Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. Given it's a 510(k) submission to the FDA, the testing was likely conducted in accordance with recognized international or US standards in accredited laboratories to support the submission.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is a physical product (gloves) undergoing standardized material and performance testing, not an AI/ML system requiring expert-established ground truth from medical images or clinical observations. The "ground truth" is established by the specifications of the ASTM standards and regulatory requirements.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-in-the-loop or expert-driven diagnostic studies, which is not relevant here. The results are based on objective measurements and compliance with specified test methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This type of study assesses the performance of AI systems in a clinical context, often with human readers. This submission is for a physical medical device (gloves) and does not involve AI or human readers for diagnostic purposes.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
- Not Applicable. This is not an algorithm or software device. The "standalone performance" refers to the glove's physical and chemical resistance properties as measured against established standards.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is defined by established ASTM (American Society for Testing and Materials) standards and FDA regulations.
- For physical properties and freedom from holes, it's compliance with ASTM D6319 and 21 CFR 800.20.
- For powder residual, it's compliance with ASTM D6319 using ASTM D6124 methodology.
- For chemotherapy permeation, it's the breakthrough time as measured according to ASTM D6978-05.
- For biocompatibility (skin irritation and sensitization), it's the observed biological response as determined by standardized tests.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of the Study Proving Device Meets Acceptance Criteria:
The device's performance was proven through a series of standardized laboratory tests detailed in the "Performance Testing" section. These tests were conducted according to recognized ASTM standards (D6319, D6124, D6978-05) and FDA regulations (21 CFR 800.20). The results consistently demonstrate that the Nitrile Cornflower Blue Powder-Free Examination Gloves meet all specified requirements for physical characteristics, freedom from holes, powder residual, primary skin irritation, potential for sensitization, and resistance to permeation by nine specific chemotherapy drugs. The specific "Minimum Breakthrough Detection Time" for each chemotherapy drug was measured to confirm its protective qualities. Based on this comprehensive testing, the manufacturer concluded that the gloves meet the technological characteristics of ASTM D6319 performance standard and are substantially equivalent to their predicate device.
§ 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.