(50 days)
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs 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 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The Powder Free Nittile Examination Gloves, Violet Blue, Test For Use With Chemotherapy Drugs 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 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Not Found
This document describes the FDA clearance for Powder Free Nitrile Examination Gloves (Blue and Violet Blue) tested for use with chemotherapy drugs. It is a 510(k) premarket notification (K220228). The core of the information provided for acceptance criteria and device performance relates to the gloves' resistance to permeation by various chemotherapy drugs.
Here's an analysis of the provided information in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion, though not explicitly stated as a pass/fail threshold, is implied by the standard ASTM D6978-05 (2019) which assesses the permeation and provides breakthrough detection times. The performance is presented as the actual breakthrough detection time for each drug. Generally, a longer breakthrough time indicates better protection. The warnings for Carmustine (BCNU) and Thio Tepa highlight cases where the performance is considered critically low.
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard and intended use) | Reported Device Performance (Breakthrough Detection Time in Minutes) - Blue Gloves | Reported Device Performance (Breakthrough Detection Time in Minutes) - Violet Blue Gloves |
|---|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | Longer breakthrough time is better; Warning for low times | 22.4 | 23.5 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | Longer breakthrough time is better | >240 | >240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Thio Tepa | 10.0 mg/ml (10,000 ppm) | Longer breakthrough time is better; Warning for low times | 73.1 | 66.6 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Warning Notes | The document explicitly states: "Don't use with either Carmustine (BCNU) or Thio Tepa" for both glove types due to low permeation times. | The document explicitly states: "Don't use with either Carmustine (BCNU) or Thio Tepa" for both glove types due to low permeation times. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for testing each drug (e.g., how many gloves were tested per drug). It indicates that the testing was performed "in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs." This standard would define the appropriate sample sizes and testing methodologies.
The data provenance is from a laboratory study evaluating the permeation of chemotherapy drugs through the gloves. The country of origin of the data is not specified, but the manufacturer is based in China. The study is prospective in nature as it involves planned testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not typically involve human experts to establish "ground truth" in the clinical sense (e.g., radiologists interpreting images). The "ground truth" for this device is the objective measurement of chemical permeation according to a standardized method (ASTM D6978-05). The experts involved would be laboratory technicians and chemists skilled in conducting these specific permeation tests and interpreting the results as per the ASTM standard. Their qualifications would likely include laboratory certifications and experience with chemical testing and material science, not clinical medical expertise.
4. Adjudication Method for the Test Set
No adjudication method is relevant here as the output is an objective, quantitative measurement (breakthrough time) according to a standardized test. There is no subjective human interpretation that would require an adjudication process.
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
No MRMC study was done, nor is it applicable to this type of device. This device is a physical barrier (gloves), not an AI diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable. The device is a physical product (gloves), not an algorithm or AI. The performance testing is "standalone" in the sense that the gloves are tested directly, without human intervention during the permeation assay itself.
7. The Type of Ground Truth Used
The ground truth used is objective laboratory measurement according to a recognized industry standard (ASTM D6978-05). This standard defines how to assess the resistance of medical gloves to permeation by chemotherapy drugs, yielding quantitative data (breakthrough detection time).
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product (gloves) that undergoes direct performance testing, not a machine learning model that requires a "training set."
9. How The Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this type of 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.