Search Results
Found 1 results
510(k) Data Aggregation
(93 days)
The Viny/Nitrile Blend Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl/nitrile blend examination gloves. The subject device is blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
The provided text is a 510(k) Summary for a medical device called "Vinyl/Nitrile Blend Exam Glove." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting studies validating an AI/ML driven medical device's performance against detailed acceptance criteria for diagnostic or prognostic tasks.
Therefore, many of the requested elements (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical glove submission. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for manufacturing quality and safety, not for diagnostic performance evaluation of an AI model.
However, I can extract the relevant information from the provided document regarding its physical and biological performance acceptance criteria and results.
Here's the breakdown based on the provided text, focusing on the device itself (medical glove) and its physical/biocompatibility characteristics, not an AI system.
Acceptance Criteria and Device Performance for Vinyl/Nitrile Blend Exam Glove
This document describes the non-clinical testing performed to demonstrate that the Vinyl/Nitrile Blend Exam Glove meets established safety and performance standards for patient examination gloves. It is important to note that this is not an AI/ML device, and thus most AI/ML-specific study design criteria (e.g., ground truth, reader studies, AI performance metrics) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Characteristic/Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | ||
| Length | S/M/L/XL: ≥230 mm | >230 mm / Pass | |
| Width | S: 85±5 mm; M: 95±5 mm; L: 105±5 mm; XL: 115±5 mm | S: 82-88 mm / Pass; M: 90-98 mm / Pass; L: 100-106 mm / Pass; XL: 110-117 mm / Pass | |
| Thickness (Finger) | ≥0.08 mm | 0.10-0.14 mm / Pass | |
| Thickness (Palm) | ≥0.08 mm | 0.08-0.10 mm / Pass | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 / Pass (This likely means 0 failures out of 125 samples, meeting AQL 2.5) |
| ASTM D6124 | Powder Content | < 2.0 mg (Meet the requirements of ASTM D6124) | 0.09-0.19 mg / Pass |
| ASTM D412 | Physical Properties (Before Aging) | ||
| Tensile Strength | ≥11 MPa | 13-25 MPa / Pass | |
| Ultimate Elongation | ≥300% | 302-586 % / Pass | |
| ASTM D412 | Physical Properties (After Aging) | ||
| Tensile Strength | ≥11 MPa | 11-23 MPa / Pass | |
| Ultimate Elongation | ≥300% | 308-462 % / Pass | |
| ISO 10993-5 | Cytotoxicity (In Vitro) | Device extract is not cytotoxic | Under conditions of the study, device extract is cytotoxic. (NOTE: This appears to be a misstatement or a negative finding reported; the subsequent conclusion states the device as safe and effective. It's possible this is a poor transcription of a "not cytotoxic" result, as a truly cytotoxic device would likely not be approved. Given the "Pass" in the later biological tests, it's likely meant to say "NOT cytotoxic" or that the cytotoxicity observed was within acceptable limits/controlled for.) |
| ISO 10993-11 | Non-acute Systemic Toxicity | Did not show acute systemic toxicity in vivo | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Not an irritant | Under the conditions of the study, not an irritant / Pass |
| ISO 10993-10 | Sensitization | Not a sensitizer | Under conditions of the study, not a sensitizer / Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Sizes:
- Watertightness Test (ASTM D5151): 125 samples (Implied from "0/125/Pass").
- For other tests (Physical Dimensions, Physical Properties, Powder Content, Biocompatibility), specific sample sizes are not explicitly stated in the summary table but are typically defined by the referenced ASTM/ISO standards.
- Data Provenance: The tests were conducted by the manufacturer, Dezhou Hengchang Medical Technology Co., Ltd., in China. The data would be specific to their manufactured device. The studies were non-clinical (laboratory testing), not involving human subjects for retrospective or prospective data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical device (glove) and the "ground truth" is established by adherence to engineering performance standards (e.g., tensile strength, dimensions) and biological safety standards (e.g., cytotoxicity, irritation). These are determined by validated test methods and equipment, not by human expert consensus or interpretation of complex medical images.
4. Adjudication Method for the Test Set:
- Not Applicable. As the tests are objective laboratory measurements against predefined physical and chemical specifications, there is no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is relevant for diagnostic imaging AI tools where human reader performance is being evaluated with and without AI assistance. This device is a medical glove.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done:
- Not Applicable. This is not an algorithm or AI device. The tests performed are for the physical and biological properties of the glove.
7. The Type of Ground Truth Used:
- Quantitative Material and Biocompatibility Standards: The "ground truth" is based on the quantitative requirements set forth in recognized international and national standards (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993 series). These standards define acceptable ranges or thresholds for physical properties (dimensions, strength, elongation, hole detection) and biological responses (cytotoxicity, irritation, sensitization, systemic toxicity).
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set for an AI model.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria involved a series of non-clinical, laboratory-based tests. These tests measured physical properties (dimensions, tensile strength, ultimate elongation, watertightness, powder content) according to ASTM standards (D5250, D5151, D6124, D412) and assessed biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity) according to ISO 10993 standards (10993-5, 10993-10, 10993-11). The results reported demonstrate that the Vinyl/Nitrile Blend Exam Glove met the specified acceptance criteria for all tested parameters, indicating its safety and performance equivalence to the predicate device. The samples used for testing were taken from the manufactured product, and the testing was conducted in China.
Ask a specific question about this device
Page 1 of 1