(78 days)
This Nitrile 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, and has also been Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
This document describes the Violet Nitrile Powder Free Patient Examination Glove. However, it is a 510(k) premarket notification for a medical device (a glove), not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and studies related to AI/ML device performance (sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, standalone performance) is not applicable to this document.
The document focuses on the glove's performance with various chemotherapy drugs and fentanyl, and provides test results based on ASTM D6978-05 (2019) for breakthrough times.
Here is the information from Section {2} that is relevant to the glove's performance:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a separate section. However, the reported "Minimum Time Breakthrough" values serve as the device's performance against the challenge of different chemicals. The implicit acceptance criterion for a protective glove would be a sufficiently long breakthrough time. The significant warnings for Carmustine and Thiotepa suggest that their breakthrough times are below a desired protective threshold for those specific chemicals.
| Chemotherapy Drug | Concentration | Reported Device Performance (Minimum Time Breakthrough) |
|---|---|---|
| Carboplatin | 10 mg/mL | >240 min. |
| Carmustine | 3.3 mg/mL | 23.2 min. |
| Cisplatin | 1 mg/mL | >240 min. |
| Cyclophosphamide | 20 mg/mL | >240 min. |
| Dacarbazine | 10 mg/mL | >240 min. |
| Docetaxel | 10 mg/mL | >240 min. |
| Doxorubicin HCL | 2 mg/mL | >240 min. |
| Etoposide | 20 mg/mL | >240 min. |
| Fluorouracil | 50 mg/mL | >240 min. |
| Gemcitabine | 38 mg/mL | >240 min. |
| Ifosfamide | 50 mg/mL | >240 min. |
| Paclitaxel | 6 mg/mL | >240 min. |
| Thiotepa | 10 mg/mL | 67.0 min. |
| Vincristine Sulfate | 1 mg/mL | >240 min. |
| Opioid & Gastric Acid | ||
| Fentanyl citrate (injectable) | 100mcg/2mL | >240 min. |
| Gastric Acid (simulated) | 0.2% NaCl+0.7% HCL | >240 min. |
| Fentanyl in Gastric Acid | 50/50 mix | >240 min. |
Warnings:
- Carmustine and Thiotepa: Have extremely low permeation times of 23.2 min and 67.0 min respectively.
- Not for Use With: Carmustine or Thiotepa.
2. Sample size used for the test set and the data provenance: Not applicable to an AI/ML device. The data shown is chemical permeation testing data for a physical product (glove). The standard ASTM D6978-05 specifies the testing methodology, including sample sizes for physical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to an AI/ML device. The "ground truth" here is the chemical breakthrough time, which is measured mechanically/chemically according to a standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to an AI/ML device. This refers to human expert judgment in AI model validation.
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 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 device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the glove's performance is experimentally measured chemical breakthrough time as per the ASTM D6978-05 standard.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. 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.