Search Results
Found 1 results
510(k) Data Aggregation
(96 days)
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Gloves 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTMD6978- 05(2019). The gloves are single use, disposable, and provided non-sterile.
The provided text describes the acceptance criteria and performance data for a medical device: "Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study of an AI algorithm. Therefore, many of the requested points related to AI/algorithm performance are not applicable.
Here's the information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are primarily based on established ASTM and ISO standards for medical gloves.
| Test | Standard (Acceptance Criteria) | Reported Device Performance (Result) |
|---|---|---|
| Physical Dimensions | ||
| Length | ASTM D6319-19: Minimum 220mm for size XS and S, 230mm for size M, L, XL | Pass |
| Palm Width | ASTM D6319-19: XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| Thickness | ASTM D6319-19: Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| Physical Properties | ||
| Before Aging | ASTM D6319-19, ASTM D412-16 (2021): Tensile strength: 14MPa, min; Ultimate elongation: 500%, min | Pass |
| After Aging | ASTM D6319-19, ASTM D412-16 (2021): Tensile strength: 14MPa, min; Ultimate elongation: 400%, min | Pass |
| Freedom from Holes | ASTM D6319-19, ASTM D5151-19 (Water leak test): G-I, AQL 2.5 (ISO 2859- 1) | Pass |
| Residual Powder | ASTM D6319-19, ASTM D6124-06 (2017): Max 2mg/glove | Pass |
| Biocompatibility | ||
| Skin Sensitization | ISO 10993-10:2021: No Skin sensitization | The sample extract elicits no sensitization reactions under the test conditions. |
| Irritation | ISO 10993-23:2021: No Skin irritation | Under the conditions of this study, the irritation response category of the test article is classified as Negligible for polar extract and Negligible for non-polar extract. |
| Acute Systemic Toxicity | ISO 10993-11:2017: Subject showed no adverse biological reaction | No death or acute systemic toxicity was observed in the mice which received injection of extract. |
| Chemotherapy Drugs Permeation (ASTM D6978-05 (2019)) | Minimum Breakthrough Detection Time (Minutes) | Minimum Breakthrough Detection Time (Minutes) |
| Carmustine (BCNU) (3.3mg/ml) | Refer to table for specific times (N/A – no general acceptance criteria provided, specific data shown) | 1.3 (Note: "Warning: Do not use with Carmustine and Thiotepa" due to extremely low permeation times) |
| Cisplatin (1mg/ml) | >240 | >240 |
| Cyclophosphamide (20mg/ml) | >240 | >240 |
| Dacarbazine (10.0 mg/ml) | >240 | >240 |
| Doxorubicin HCl (2 mg/ml) | >240 | >240 |
| Etoposide (20mg/ml) | >240 | >240 |
| Fluorouracil (50mg/ml) | >240 | >240 |
| Paclitaxel (6mg/ml) | >240 | >240 |
| Thiotepa (10mg/ml) | Refer to table for specific times (N/A – no general acceptance criteria provided, specific data shown) | 1.1 (Note: "Warning: Do not use with Carmustine and Thiotepa" due to extremely low permeation times) |
| Fentanyl Citrate Permeation (ASTM D6978-05 (2019)) | Minimum Breakthrough Detection Time (Minutes) | Minimum Breakthrough Detection Time (Minutes) |
| Fentanyl Citrate Injection, 100mcg/2ml | >240 | >240 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves for physical dimensions, number of test replicates for permeation). However, the standard ASTM D6319-19 for physical dimensions and freedom from holes, and ASTM D6978-05 for permeation, typically define the sampling plans.
The data provenance is from "Yue Kang Anhui Medical Products Co., Ltd" in China. The studies are non-clinical performance tests, conducted to verify the device meets design specifications and relevant standards. They are retrospective in the sense that they are tests performed on manufactured products, not prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This document is for a medical glove, and the "ground truth" for the test set is established by the specifications of industrial standards (ASTM, ISO) and laboratory testing methodologies, not by expert medical review or consensus on images/data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the compliance is determined by adherence to standardized test methods and their defined acceptance criteria. There is no human adjudication process involved in these performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This is a submission for a physical medical device (glove) and does not involve an AI algorithm or human-in-the-loop performance evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a medical glove, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" here is defined by the technical specifications and performance requirements outlined in the referenced industry standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D412-16, ASTM D6978-05, ISO 10993-10, ISO 10993-23, ISO 10993-11). These standards represent established, objective, and reproducible test methods for evaluating medical glove performance and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1