(133 days)
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
The Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, is a disposable device made of synthetic latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs. A coating of Aliphatic Polyester Polyurethane is applied to the inner surface of the glove to make donning easy.
Here's a breakdown of the acceptance criteria and study information for the Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, as derived from the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D3577-09e1 | Meets |
| Physical Properties | ASTM D3577-09e1 | Meets |
| Freedom from Holes | ASTM D3577-09e1, ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 (≤ 2 mg per glove) | ≤ 2 mg per glove |
| Protein Content | ASTM D3577-09e1, ASTM D 5712 (Maximum 50 µg/dm²) | Maximum 50 µg/dm² |
| Biocompatibility | Dermal Sensitization (Passes) | Passes |
| Primary Skin Irritation Study (Passes) | Passes | |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Average breakthrough detection time in minutes) | Carmustine: 15.5 min |
| Cyclophosphamide: >240 min | ||
| Doxorubicin Hydrochloride: >240 min | ||
| Etoposide (Toposar): >240 min | ||
| 5-Fluorouracil: >240 min | ||
| Paclitaxel (Taxol): >240 min | ||
| ThioTEPA: 15.5 min | ||
| Methotrexate: >240 min | ||
| Vincristine Sulfate: >240 min |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for testing each characteristic. However, the testing was done against established ASTM (American Society for Testing and Materials) standards. These standards typically specify appropriate sample sizes and testing methodologies. The data provenance is not explicitly mentioned regarding country of origin or whether it was retrospective or prospective, but it implies prospective testing conducted to meet the specified ASTM standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The "ground truth" for the device's performance is established by meeting the specified ASTM standards, which are objective, standardized tests for physical and chemical properties. These standards do not typically rely on "expert consensus" in the same way clinical diagnostic devices might.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. The testing performed is objective and based on established ASTM methods, not on interpretation or consensus among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted. The device is a surgical glove, and its effectiveness is measured by its physical properties and barrier protection, not by human reader interpretation of images or data.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study was not conducted. This concept is relevant for AI/software-as-a-medical-device. The device in question is a physical product (surgical gloves).
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The "ground truth" for this device is based on objective measurements and results from standardized laboratory tests according to ASTM and ISO standards. This includes:
- Physical measurements (e.g., dimensions, force at break).
- Chemical analysis (e.g., powder residue, protein content).
- Barrier integrity testing (e.g., freedom from holes, chemotherapy drug permeation).
- Biocompatibility assessments (dermal sensitization, primary skin irritation).
8. Sample Size for the Training Set:
This information is not applicable/provided. The device is a physical product, not an AI algorithm that requires a "training set." Manufacturing processes are designed to produce gloves meeting specifications, and quality control systems ensure adherence to these specifications.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided for the reasons stated above.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).