(64 days)
Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs glove is a disposable device intended for medical purpose 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 ug/cm2/minute |
|---|--------------------------------------------------|-----------------------------------------------------------------------|
| 1 | Cisplatin, 1.0 mg/ml (1,000ppm) | >240 |
| 2 | Cyclophosphamide (Cytoxan),20.0mg/ml (20,000ppm) | >240 |
| 3 | Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | >240 |
| 4 | Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| 5 | Etoposide (Toposar), 20.0 mg/ml (20,000)ppm | >240 |
| 6 | Fluorouracil, 50.0 mg/ml (50,000ppm) | >240 |
| 7 | Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | >240 |
| 8 | Carmustine (BCNU)3.3mg/ml(3,300ppm) | 0.9 |
| 9 | Thiotepa, 10.0mg/ml (10,000ppm) | 0.05 |
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)3.3mg/ml(3,300ppm) Thiotepa, 10.0mg/ml ( 10,000ppm)
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This document details the acceptance criteria and performance for "Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs" in the context of their ability to prevent permeation by chemotherapy drugs.
1. Table of Acceptance Criteria and Reported Device Performance
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection time in Minutes, >0.01 ug/cm²/minute) | Reported Device Performance (Breakthrough Detection time in Minutes, 0.01 ug/cm²/minute) |
|---|---|---|
| Cisplatin, 1.0 mg/ml (1,000ppm) | >240 | >240 |
| Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000ppm) | >240 | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | >240 | >240 |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 | >240 |
| Etoposide (Toposar), 20.0 mg/ml (20,000ppm) | >240 | >240 |
| Fluorouracil, 50.0 mg/ml (50,000ppm) | >240 | >240 |
| Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | >240 | >240 |
| Carmustine (BCNU) 3.3mg/ml (3,300ppm) | Not explicitly stated as acceptance criteria (note indicates "extremely low permeation time") | 0.9 |
| Thiotepa, 10.0mg/ml (10,000ppm) | Not explicitly stated as acceptance criteria (note indicates "extremely low permeation time") | 0.05 |
Note: The document specifies that the maximum testing time is 240 minutes. For Carmustine and Thiotepa, while specific acceptance criteria in the ">X" format are not given, the note highlights their extremely low permeation times, which can be interpreted as a disclosure rather than a failure of an acceptance criterion that requires >240 minutes.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided document. The study refers to testing in accordance with ASTM D6978-05. The sample size would be dictated by the requirements of this standard.
- Data Provenance: Not explicitly stated. The testing was performed in accordance with ASTM D6978-05, which is an international standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes a physical performance test for medical gloves against chemotherapy drugs, not a diagnostic or clinical AI study. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense does not apply here. The "ground truth" is the objective measurement of breakthrough time, determined by standardized laboratory procedures.
4. Adjudication method for the test set
Not applicable. This is a laboratory performance test based on a standardized methodology (ASTM D6978-05), not a situation requiring expert adjudication of subjective assessments.
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 document pertains to the physical performance of a medical device (gloves), not an AI-assisted diagnostic or imaging system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical performance test of a medical device (gloves), not an algorithm.
7. The type of ground truth used
The ground truth used is the objective measurement of chemotherapy drug permeation breakthrough time, determined by a standardized laboratory method, specifically ASTM D6978-05. This is a quantitative, empirical measurement.
8. The sample size for the training set
Not applicable. This is a physical performance test for a medical device (gloves), not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI model, there is no training set or ground truth for a training set in this context.
§ 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.