(58 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey) is a non-sterile disposable device intended for medical purpose 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The provided document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)". This document does not pertain to an AI/ML medical device and therefore does not include the typical information about acceptance criteria, study design, and ground truth establishment relevant to AI/ML products.
Instead, this document focuses on the chemical permeation resistance of the examination gloves to various chemotherapy drugs and Fentanyl Citrate. The "acceptance criteria" here relate to the minimum breakthrough detection time for these chemicals, as per a specific ASTM standard.
Here's a breakdown of the information that can be extracted from the provided text, adapted to the requested format where possible, and noting where the requested information is not applicable (N/A) for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance (Breakthrough Detection Time for Chemical Permeation)
The study referenced is based on ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The acceptance criteria are implied by the standard, where a longer breakthrough time indicates better protection. While specific 'acceptance criteria' values (e.g., "must be > X minutes") are not explicitly stated as pass/fail thresholds in this summary, the results demonstrate the performance against the standard's methodology. The crucial findings for two drugs are highlighted as warnings.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Implied by standard and context of demonstrating protection) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (3.3 mg/ml) | Longer breakthrough time indicates better performance. | 12.9 |
| Cisplatin (1.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Cyclophosphamide (20.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Dacarbazine (10.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Etoposide (20.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Fluorouracil (50.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Methotrexate (25.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Mitomycin C (0.5 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Paclitaxel (6.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Thiotepa (10.0 mg/ml) | Longer breakthrough time indicates better performance. | 45.0 |
| Vincristine Sulfate (1.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Azacytidine (25.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Carboplatin (10.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Docetaxel (10 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Epirubicin (2.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Gemcitabine (38 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Ifosfamide (50 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Irinotecan (20 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Mitoxantrone (2.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Oncovin (1.0 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Oxaliplatin (5 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Vinorelbine (10 mg/ml) | Longer breakthrough time indicates better performance. | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | Longer breakthrough time indicates better performance. | >240 |
Warnings: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 12.9
minutes and 45.0 minutes respectively. Warning: Do not use with Carmustine. Warning: Do not use with Thiotepa." This suggests an implicit acceptance criterion where these breakthrough times are deemed insufficient for safe use, leading to a contraindication.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in the provided document. The ASTM D6978-05 standard would specify the number of glove samples to be tested per drug.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing would have been conducted in a laboratory setting according to the ASTM standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is N/A for the current device. The "ground truth" here is the measured chemical breakthrough time, determined by laboratory instruments and testing procedures defined in the ASTM standard, not by expert interpretation.
4. Adjudication method for the test set:
- This is N/A for the current device. Chemical permeation testing does not involve 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:
- This is N/A for the current device. This is not an AI/ML device, and no human reader study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is N/A for the current device. This is not an AI/ML device. The performance reported is for the physical glove material itself.
7. The type of ground truth used:
- The "ground truth" for this study is direct laboratory measurement of chemical permeation, quantified as Minimum Breakthrough Detection Time, as determined by the ASTM D6978-05 standard.
8. The sample size for the training set:
- This is N/A for the current device. There is no AI/ML model involved, hence no training set. The gloves are manufactured based on established material science and manufacturing processes, with testing conducted to verify performance characteristics.
9. How the ground truth for the training set was established:
- This is N/A for the current device, as there is no training set for an AI/ML model.
§ 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.