(132 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 26.2 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 59.1 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 26.2 and 59.1 minutes respectively.
Fentanyl Citrate and Concentration Fentanyl Citrate Injection (100 mcg/2ml) Minimum Breakthrough Detection Time in Minutes >240
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
This document is a 510(k) Premarket Notification from the FDA for a medical device: "Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate."
It describes the Indications for Use and provides test results related to its performance with chemotherapy drugs and Fentanyl Citrate. However, it does not include information about AI/algorithm performance, ground truth establishment, expert review, or sample sizes related to AI studies. Therefore, many of the requested categories cannot be populated from the provided text.
Here is the information that can be extracted or deduced from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for glove performance against permeation by chemotherapy drugs and Fentanyl Citrate are implied by the standard used (ASTM D6978-05 (Reapproved 2013)) and the reporting of "Minimum Breakthrough Detection Time in Minutes." While an explicit numeric acceptance threshold isn't stated as "acceptance criteria" in the table heading, the values themselves represent the device's performance against relevant standards.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 26.2 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 59.1 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Note: The document explicitly states: "Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 26.2 and 59.1 minutes respectively." This highlights these drugs as having lower breakthrough times compared to others.
Information Not Available in the Provided Text:
The following information cannot be extracted from the provided FDA 510(k) document because it pertains to the evaluation of an Artificial Intelligence (AI) or algorithm-based device, whereas this document describes a physical medical device (examination gloves).
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device, not an AI/algorithm. The "test set" would refer to the gloves tested against various chemicals, but detailed sample sizes for the chemical permeation tests are not provided beyond the results themselves.
- 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 for a physical medical device. Ground truth for chemical permeation is typically established by instrumental analysis according to a standard.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a physical medical device.
- 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, as this is a physical medical device, not an AI/algorithm designed to assist human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI/algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove's performance, the ground truth is established by the standardized testing methodology (ASTM D6978-05) involving chemical permeation measurements. This is an objective, laboratory-based physical test rather than a clinical ground truth like pathology or expert consensus.
- The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable, as this is a physical medical device, not an AI/algorithm.
§ 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.