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510(k) Data Aggregation
(97 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
This document is a 510(k) Pre-market Notification for medical gloves, focusing on their resistance to chemotherapy drugs. It details the performance of "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Original Blue, Cobalt Blue)" against a range of chemotherapy agents.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for chemotherapy drug permeation are defined by the "Average Breakthrough Detection Time" for each drug. While the specific numerical acceptance criteria (e.g., minimum time) are not explicitly stated as distinct "criteria" separate from the results, the implication is that the longer the breakthrough time, the better the performance. For many drugs, a breakthrough time of "> 240 minutes" is presented, suggesting this is a desirable outcome or a de facto acceptance benchmark for long-term protection. The device performance is the directly measured average breakthrough detection time for each drug.
Below are the tables summarizing the performance for both "Original Blue" and "Cobalt Blue" glove variations, as tested against various chemotherapy drugs.
Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs - Original Blue
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
|---|---|
| Carboplatin, 10 mg/ml | > 240 |
| Carmustine (3.3 mg/ml) | 1.84 |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 |
| Etoposide (Toposar), 20.0 mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Methotrexate, 25 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 |
| Mitoxantrone, 2 mg/ml | > 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| ThioTEPA (10.0 mg/ml) | 0.76 |
| Vincristine Sulfate, 1.0 mg/ml | > 240 |
| Warning for drugs with extremely low permeation time: | Carmustine (3.3 mg/ml): 1.84 minutes |
| ThioTEPA (10.0 mg/ml): 0.76 minutes |
Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs - Cobalt Blue
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
|---|---|
| Carboplatin, 10 mg/ml | > 240 |
| Carmustine (3.3 mg/ml) | 1.82 |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 |
| Etoposide (Toposar), 20.0 mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Methotrexate, 25 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 |
| Mitoxantrone, 2 mg/ml | > 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| ThioTEPA (10.0 mg/ml) | 0.93 |
| Vincristine Sulfate, 1.0 mg/ml | > 240 |
| Warning for drugs with extremely low permeation time: | Carmustine (3.3 mg/ml): 1.82 minutes |
| ThioTEPA (10.0 mg/ml): 0.93 minutes |
In addition to chemotherapy drug permeation, the gloves were also tested against other specifications, including:
| Characteristic | Standard | Acceptance Criteria | Device Performance (Original Blue) | Device Performance (Cobalt Blue) |
|---|---|---|---|---|
| Dimension | ASTM D6319-10 | Minimum 240mm length | Minimum 240mm | Minimum 240mm |
| Physical Properties | ASTM D6319-10 | Meets standard requirements | Meets | Meets |
| Thickness | ASTM D6319-10 | Finger 0.07-0.10mm (Predicate 1), 0.10min (Predicate 2); Palm 0.07-0.09mm; Cuff 0.06-0.08mm (Predicate 1), Not specified (Cuff, Predicate 2) | Finger 0.09-0.14mm; Palm 0.07-0.10mm; Cuff 0.06-0.09mm | Finger 0.10min; Palm 0.07-0.09mm; Cuff 0.05-0.08mm |
| Powder-free | ASTM D6124-06 (<2mg/glove) | Meets standard requirements (less than 2mg/glove) | Meets | Meets |
| Bio-compatibility | ISO 10993-10 (2010), Consumer Product Safety Commission | Not a primary skin irritant; Not a contact sensitizer | Under the condition of the study the device is non-irritant; Under the condition of the study the device is non-sensitizer | Under the condition of the study the device is non-irritant; Under the condition of the study the device is non-sensitizer |
| Water tightness | ASTM D5151-06 | Passes (1000ml) | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for testing each individual chemotherapy drug permeation or other properties. However, it does state that the device "meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250." These ASTM standards would typically define the appropriate sample sizes and testing methodologies.
The data provenance is not specified, but the submission is from "YTY Industry (Manjung) Sdn. Bhd., Malaysia," suggesting the tests were likely conducted on products manufactured or supervised by this Malaysian entity. The tests appear to be a prospective evaluation of the device's performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes performance testing of physical properties and chemical permeation resistance of gloves, not diagnostic or clinical interpretation. Therefore, the concept of "experts used to establish ground truth" as it would apply to image analysis or clinical diagnosis is not applicable here. The "ground truth" is established by adherence to recognized industrial standards (ASTM D6319-10 and D6978-05) and FDA regulations. These standards define the scientific methods and procedures for evaluating glove performance.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a device (often AI-based) on human reader performance in tasks like diagnostic interpretation. This document pertains to the physical and chemical performance of medical gloves, not assistive diagnostic technology.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, a standalone performance assessment was done. The entire study described is a standalone evaluation of the glove's performance against various physical and chemical challenges, without human-in-the-loop interaction in the context of diagnostic interpretation. The breakthrough detection times and physical properties are direct measurements of the device's inherent characteristics.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and scientific testing procedures. Specifically:
- ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: This standard outlines the methodology for determining the breakthrough detection time of chemotherapy drugs through glove material.
- ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application: This standard sets specifications for physical properties like dimensions, physical performance, and powder content.
- ISO 10993-10 (2010) and Consumer Product Safety Commission II, Part 1500: These standards govern biocompatibility testing (primary skin irritation and dermal sensitization).
- ASTM D5151-06: This standard relates to water tightness testing.
The results obtained through these standardized testing methods serve as the "ground truth" for the device's performance.
8. The Sample Size for the Training Set
Not applicable. This device is a medical glove, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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