(149 days)
The Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
The gloves were tested with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
This FDA 510(k) clearance letter pertains to medical examination gloves and does not describe an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, expert qualifications, ground truth establishment methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.
The document focuses on the performance of a physical medical device (gloves) against specific chemical permeation tests.
Here's the relevant information based on the provided text, focusing on the acceptance criteria and study for the gloves:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is evaluated based on its resistance to permeation by chemotherapy drugs and Fentanyl Citrate. The acceptance criterion is implied by the testing methodology using ASTM D6978-05, aiming for a long breakthrough detection time. While an explicit "acceptance criteria" value isn't stated in the table for each drug, the "Average Breakthrough Detection Time (mins)" provides the reported performance directly. For most drugs, a breakthrough time of "> 240 minutes" is presented, indicating good resistance for at least 4 hours.
| Test drug and concentration | Acceptance Criteria (Implied: High DBT) | Reported Device Performance (Average Breakthrough Detection Time (mins)) |
|---|---|---|
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | High DBT | 13.5 |
| Cisplatin, 1.0 mg/ml (1,000 ppm) | High DBT | > 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) | High DBT | > 240 |
| Dacarbazine, 10.0 mg/ml (10,000 ppm) | High DBT | > 240 |
| Doxorubicin HCL, 2.0 mg/ml (2,000 ppm) | High DBT | > 240 |
| Etoposide, 20.0 mg/ml (20,000 ppm) | High DBT | > 240 |
| Fluorouracil, 50.0 mg/ml (50,000 ppm) | High DBT | > 240 |
| Ifosfamide, 50.0 mg/ml (50,000 ppm) | High DBT | > 240 |
| Methotrexate, 25.0 mg/ml (25,000 ppm) | High DBT | > 240 |
| Mitomycin, 0.5 mg/ml (500 ppm) | High DBT | > 240 |
| Mitoxantrone, 2.0 mg/ml (2,000 ppm) | High DBT | > 240 |
| Paclitaxel, 6.0 mg/ml (6.000 ppm) | High DBT | > 240 |
| ThioTepa, 10.0 mg/ml (10,000 ppm) | High DBT | 19.0 |
| Vincristine Sulfate, 1.0 mg/ml (1,000 ppm) | High DBT | > 240 |
| Fentanyl Citrate Injection, 100 mcg/2ml | High DBT | > 240 |
Note: The cautionary statement "CAUTION: Do not use with Carmustine and ThioTepa" implies that the breakthrough times for these two drugs (13.5 and 19.0 minutes respectively) are considered insufficient for safe use, effectively setting an implicit acceptance criterion that these drugs fail it for prolonged exposure.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set (number of gloves tested per drug). It only refers to a standard test method. The data provenance is not explicitly stated beyond being the result of testing the manufacturer's "Powder-Free Green Biodegradable Nitrile Examination Glove." The testing is prospective for the purpose of this submission. The country of origin of the data is not specified, but the manufacturer is based in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a physical device performance test (chemical permeation), not an AI/ML diagnostic or image interpretation. "Ground truth" in this context is the objective measurement of chemical breakthrough time, typically conducted in a laboratory by trained technicians following a standardized protocol.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a physical device performance test, not involving human interpretation or adjudication in the sense of comparing opinions. The results are quantitative measurements.
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/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device is the objective measurement of chemical permeation/breakthrough time determined by laboratory testing protocols, specifically ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered 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.