(91 days)
A Powder Free Nitrile Examination Glove - Blue (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05
Powder Free Nitrile Examination Glove - Blue (Chemotherapy)
The provided document outlines the FDA's substantial equivalence determination for a medical device, specifically "Powder Free Nitrile Examination Glove -- Blue (Chemotherapy)." The primary focus of the document regarding performance is the permeation resistance of these gloves to various chemotherapy drugs.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For chemotherapy gloves, the critical acceptance criterion is the Minimum Breakthrough Detection Time when exposed to specific chemotherapy drugs. The device performance is measured against this criterion. While the document doesn't explicitly state "acceptance criteria" for each drug with a numerical threshold (e.g., "must be > X minutes"), it presents the test results, implying that demonstrating adequate permeation resistance for a certain duration is the goal. For the purpose of this analysis, the reported breakthrough detection times serve as the device's performance against an implicit criterion of maintaining barrier integrity for a reasonable period.
| Test Chemotherapy Drug and Concentration | Acceptance Criteria (Implicit: sufficiently high breakthrough time) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU), 3.3 mg/ml | Not explicitly stated, but demonstrating barrier integrity is key | 60.3 (60.3, 60.5, 60.6) |
| Cisplatin, 1.0 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Dacarbazine (DTIC), 10.0 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Doxorubicin Hydrochloride, 2.0 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Etoposide (Toposar), 20.0 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Fluorouracil, 50.0 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Ifosfamide, 50.0 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Methotrexate, 25 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Mitomycin C, 0.5 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Mitoxantrone, 2 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Paclitaxel (Taxol), 6.0 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
| Thiotepa, 10.0 mg/ml | Not explicitly stated | 156.0 (163.8, 156.0, 165.0) |
| Vincristine Sulfate, 1.0 mg/ml | Not explicitly stated | No breakthrough up to 240 min. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For each chemotherapy drug, the breakthrough detection time is reported with values for three specimens (e.g., "(60.3, 60.5, 60.6)"). Therefore, the sample size for the test set regarding permeation was 3 specimens per drug.
- Data Provenance: The document does not specify the country of origin of the data. It is a submission to the FDA from a Malaysian company (Matang Manufacturing Sdn. Bhd, Melaka, Malaysia). The study appears to be prospective testing specifically conducted for this 510(k) submission, rather than retrospective data analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The study described is a laboratory test (permeation test) conducted according to a standard (ASTM D 6978-05). It does not involve human interpretation or subjective assessment that would require "experts" to establish a ground truth in the typical sense of clinical studies (e.g., radiologists interpreting images). The "ground truth" here is the objective chemical permeation through the glove material as measured by the testing method.
4. Adjudication Method for the Test Set
- This information is not applicable as the study is a laboratory permeation test, not a study involving human interpretation or subjective assessment that would require an adjudication method among experts. The results for each specimen are reported independently.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, And What Was the Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve multiple readers (e.g., physicians) interpreting cases (e.g., medical images) with and without AI assistance. The described study is a laboratory material performance test for gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a physical product (examination glove), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply. The performance reported is that of the physical device under laboratory conditions.
7. The Type of Ground Truth Used
- The "ground truth" used is based on objective laboratory measurements of chemical permeation through the glove material, as defined by ASTM D 6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs). This standard outlines validated methods for determining breakthrough time. It is a direct physical measurement, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- This information is not applicable. The device is a physical product (glove) whose performance is determined through physical testing, not through a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as in point 8.
§ 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.