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510(k) Data Aggregation
(177 days)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating and is yellow in color.
The glove are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.
The provided document describes the acceptance criteria and the study for "Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)." This is a medical device, specifically a surgical glove, and the study focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. There is no AI component mentioned in this documentation, therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training) are not applicable.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against various standards, primarily ASTM D3577 for surgical gloves and ASTM D6978 for chemotherapy drug permeation.
| Characteristic | Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10 Guidance | Non-Irritating, under the conditions of the study |
| Guinea Pig Maximization (Sensitization) | ISO 10993-10 Guidance | Non-sensitizing, under the conditions of the study |
| Physical Characteristics | ||
| Dimensions | ASTM D3577 requirements | Meets requirements |
| Physical Properties | ASTM D3577 requirements for synthetic surgical gloves | Meets requirements |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 requirements of AQL 1.5; ASTM D 5151 test method | Tested in accordance with ASTM D 5151 and meets 21CFR 800.20 & ASTM D3577 requirements of AQL 1.5 |
| Powder Residual | ASTM D3577: ≤2.0 mg/glove for Powder-Free designation; ASTM D6124 test method | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values < 2mg of residual powder per glove. |
| Chemotherapy Drug Permeation | ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Minimum Breakthrough Detection Time 0.01 µg/cm²/minute | For 9 out of 11 chemotherapy drugs tested, the minimum normalized breakthrough detection times exceeded the maximum testing time of 240 minutes. Carmustine (BCNU) (3.3 mg/ml) showed a permeation time of 60.1 minutes, and Thiotepa (10 mg/ml) showed a permeation time of 110.5 minutes. (Specific values are listed in the Chemotherapy Drug Permeation Time table on page 3 and 6). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the various material tests. However, the tests are laboratory-based, adhering to international and ASTM standards. The provenance of the data is from Cardinal Health's testing, conducted for the purpose of FDA submission. The studies are by nature prospective, as they are performed on the device to prove its compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. These are physical and chemical performance tests, not clinical evaluations requiring human expert interpretation in the context of medical images or diagnoses. The "ground truth" for these tests is defined by the standards themselves (e.g., a specific breakthrough time, a dimensional tolerance, a AQL limit).
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements against predefined criteria/standards.
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
Not applicable. This device is a surgical glove, not an AI-powered diagnostic tool. There are no human readers or AI involved in its performance evaluation as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for performance assessment is based on established industry standards and regulatory requirements. For example:
- Physical properties (dimensions, tensile strength) are compared against ASTM D3577.
- Freedom from holes is assessed against 21 CFR 800.20 and ASTM D3577 AQL 1.5, using ASTM D5151.
- Powder residual is assessed against ASTM D3577 (< 2mg/glove), using ASTM D6124.
- Biocompatibility is assessed against ISO 10993-10 guidance (non-irritating, non-sensitizing).
- Chemotherapy drug permeation is assessed against ASTM D6978 (minimum breakthrough detection time).
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical device, not an AI algorithm.
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