(244 days)
A 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. Tested for use with Chemotherapy Drugs
The BioClean Chemo Shield is a powder free, sterile, Polychloroprene examination glove, tested for use with chemotherapy agents.
The BioClean Chemo Shield is a patient examination glove. The acceptance criteria and performance data for this device are detailed in the provided document, primarily focusing on non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test (Standard) | Performance |
|---|---|
| Dimensions (ASTM D 6977-04) | Met |
| Physical properties (ASTM D 6977-04) | Met |
| Freedom from pinholes (ASTM D 6977-04) | Met |
| Freedom from pinholes (ASTM D 5151-06) | Met |
| Powderfree (ASTM D 6124-06) | Met |
| Biocompatibility (ISO 10993-10: 2002) | Met |
| Resistance to permeation (ASTM D 6978-05) | Breakthrough Detection Time (minutes) |
| Cisplatinum, 1.0 mg/mL | No Breakthrough up to 480 |
| Carmustine, 3.3 mg/mL | 50.3 |
| Cyclophosphamide, 20.0 mg/mL | No Breakthrough up to 480 |
| DoxorubicinHydrochloride | No Breakthrough up to 480 |
| 5-Fluorouracil, 50.0 mg/mL | No Breakthrough up to 480 |
| Methotrexate, 25.0 mg/mL | No Breakthrough up to 480 |
| Etoposide, 20.0 mg/mL | No Breakthrough up to 480 |
| Paclitaxel (Taxol), 6.0 mg/mL | No Breakthrough up to 480 |
| Thio-Tepa, 10.0 mg/mL | 107.7 |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of gloves tested for pinholes, dimensions, or permeation). The data provenance is derived from laboratory testing against established ASTM and ISO standards, indicating a controlled, prospective testing environment rather than retrospective data. The location of the submitter, Nitritex (M) Sdn. Bhd., is Malaysia, so the testing could have occurred there or at a certified lab elsewhere.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for these non-clinical tests is established by standardized testing protocols (ASTM, ISO) and laboratory measurements rather than expert human interpretation.
4. Adjudication method for the test set:
Not applicable. The reported performance metrics are objective measurements from standardized tests, not subjective interpretations requiring 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 a patient examination glove, and its performance is evaluated through non-clinical laboratory testing, not through human reader interpretation or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product (a glove), not an algorithm or AI system.
7. The type of ground truth used:
The ground truth used for the device's acceptance criteria is based on established industry standards and laboratory measurements. For physical properties, it's defined by the specifications outlined in ASTM D 6977-04. For freedom from pinholes, it's ASTM D 6977-04 and ASTM D 5151-06. For powder content, it's ASTM D 6124-06. For biocompatibility, it's ISO 10993-10: 2002. Notably, for resistance to chemotherapy agent permeation, the ground truth is the chemical breakthrough detection time as measured according to ASTM D 6978-05.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this product.
§ 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.