(45 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.
Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
The provided text describes the 510(k) premarket notification for "Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs" and includes information about the device's indications for use and performance related to chemotherapy drug permeation. Based on the document, I can extract the acceptance criteria and performance data for chemotherapy drug permeation. However, the document does NOT contain information about a study that would typically include details like sample size for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established in the context of an AI/algorithm-based device. This document is a regulatory submission for a physical medical glove, not an AI/software device.
Therefore, I will only be able to populate the acceptance criteria and device performance table, and explain why other requested information is not applicable to this document.
Acceptance Criteria and Reported Device Performance
| No. | Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time (Minutes)) | Reported Device Performance (Breakthrough Detection Time (Minutes)) |
|---|---|---|---|
| 1 | Carboplatin (10.0 mg/ml) | >240 | >240 |
| 2 | Carmustine (BCNU) (3.3 mg/ml) | A specific minimum clinical threshold for breakthrough time would be the acceptance criteria. The document states a breakthrough time of 3.0 minutes, which is relatively low compared to others. | 3.0 |
| 3 | Cisplatin (1.0 mg/ml) | >240 | >240 |
| 4 | Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 | >240 |
| 5 | Cytarabine (100.0 mg/ml) | >240 | >240 |
| 6 | Dacarbazine (DTIC) (10.0 mg/ml) | >240 | >240 |
| 7 | Docetaxel (10.0 mg/ml) | >240 | >240 |
| 8 | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | >240 |
| 9 | Etoposide (Toposar) (20.0 mg/ml) | >240 | >240 |
| 10 | Fluorouracil (50.0 mg/ml) | >240 | >240 |
| 11 | Mechlorethamine HCl (1.0 mg/ml) | >240 | >240 |
| 12 | Methotrexate (25.0 mg/ml) | >240 | >240 |
| 13 | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | >240 |
| 14 | Thiotepa (10.0 mg/ml) | A specific minimum clinical threshold for breakthrough time would be the acceptance criteria. The document states a breakthrough time of 75.0 minutes, which is lower than many others. | 75.0 |
Note on Acceptance Criteria: For most drugs listed, the implied acceptance criterion is "greater than 240 minutes" of breakthrough detection time, as the device performance meets or exceeds this value for 12 out of 14 drugs. For Carmustine (BCNU) and Thiotepa, the document explicitly notes their "extremely low permeation time" and reports specific values (3.0 and 75.0 minutes, respectively). Therefore, the acceptance criteria for these specific drugs would be defined by the regulatory standard (ASTM D6978-05) and deemed acceptable given the specific performance measured.
Study Details (Information Not Applicable to this Document Type)
The provided document is a 510(k) clearance letter for a physical medical device (examination gloves). It describes the device's intended use and includes testing results for permeation by chemotherapy drugs, conducted in accordance with ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs).
The questions you've asked (regarding sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set ground truth) are typically relevant for studies evaluating Artificial Intelligence (AI) or machine learning algorithms/devices.
Since this document pertains to a physical product (nitrile gloves) and its material properties, the concepts of "test set," "training set," "experts to establish ground truth," "adjudication method," "MRMC study," or "standalone (algorithm only) performance" are not applicable in this context. The "study" referenced is the physical permeation test conducted according to the ASTM standard, not a data-driven AI model evaluation.
Therefore, the requested details are not present in this document because they are not relevant to the type of device and evaluation described.
§ 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.