(112 days)
Uweport Powder-Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs is a nonsterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Uweport Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These powder-free gloves are made of synthetic biocompatible copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are available in small, medium, large, and extra-large.
The provided document pertains to the 510(k) premarket notification for Uweport Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. This is a submission for a Class I medical device (examination gloves) and as such, the performance criteria and data provided are related to the physical and chemical properties of the gloves, particularly their resistance to permeation by chemotherapy drugs, and not to an AI/ML-based diagnostic or prognostic device.
Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, AI/ML training set information) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding acceptance criteria and study results for this specific device type:
Acceptance Criteria and Device Performance for Uweport Powder-Free Nitrile Examination Gloves
This summary addresses the performance of Uweport Powder-Free Nitrile Examination Gloves, focusing on their resistance to chemotherapy drug permeation as per the FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The primary performance criterion for these gloves, beyond general examination glove standards, is their resistance to permeation by chemotherapy drugs. This was assessed according to ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The acceptance criteria are "Per standard," implying that the breakthrough detection times must meet or exceed a specific threshold or be reported as determined by the standard.
| Drug Tested | Concentration | Acceptance Criteria (Breakthrough Detection Time in Minutes) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | Per ASTM D6978-05(2019) Standard* | 22.8 |
| Cisplatin | 1 mg/ml (1,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Doxorubicin | 2 mg/ml (2,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Etoposide | 20 mg/ml (20,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Paclitaxel | 6 mg/ml (6,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| ThioTepa | 10.0 mg/ml (10,000 ppm) | Per ASTM D6978-05(2019) Standard* | 46.8 |
* The "Per standard" acceptance criteria imply that the results obtained are consistent with the methodology and reporting requirements of the ASTM D6978-05(2019) standard, validating the glove's performance for labeled use, even if the permeation time is relatively short for certain drugs. The warning explicitly states that the gloves are "Not recommended for use with Carmustine and Thiotepa" due to their low permeation times.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (number of gloves) used for the chemotherapy drug permeation testing. However, the testing was conducted according to ASTM D6978-05(2019), which specifies sample preparation and testing methods. For general glove properties like "Freedom from Holes," the sample size is specified as 125 samples from a batch of 35,000, with an inspection level 1 and a criterion of ≤7 non-conforming items for AQL = 2.5.
Data Provenance: The tests appear to be laboratory-based performance tests, likely conducted in a controlled environment to meet the ASTM standard. The country of origin of the data is not specified, but it's generated for an FDA 510(k) submission in the United States. The data is prospective in the sense that the tests were performed specifically to evaluate the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a performance specification test for a physical medical device (gloves), not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in the clinical sense. The "ground truth" for permeation is determined by laboratory measurement according to the specified ASTM standard.
4. Adjudication Method for the Test Set
Not applicable. This is a laboratory performance test, not a clinical study involving human interpretation or 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 device is an examination glove, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the chemotherapy drug permeation test is established by objective, quantitative laboratory measurements of breakthrough detection time according to the ASTM D6978-05(2019) standard.
For other properties, the ground truth is also established by specific ASTM standards:
- Physical Properties (Tensile Strength, Elongation): ASTM D6319-19
- Freedom from Holes: ASTM D5151-19
- Residual Powder: ASTM D6124
- Biocompatibility: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Irritation), ISO 10993-11 (Acute Systemic Toxicity).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device. The manufacturing processes and material formulations are based on established engineering and materials science principles for glove production, rather than data-driven learning.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" as this is not an AI/ML 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.