Search Results
Found 1 results
510(k) Data Aggregation
(105 days)
The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.
Here's a breakdown of the acceptance criteria and the study information for the Medical Nitrile Examination Gloves (Model: JL001), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Test Purpose | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| ASTM D6319-19 (Physical Dimensions) | To determine the width, length, and thickness of the gloves | Width:For S: 80±10 mmFor M: 95±10 mmFor L: 110±10 mmFor XL: 120±10 mmLength:For S: ≥220mmFor M/L/XL: ≥230mmFinger Thickness: min. 0.05 mmPalm Thickness: min. 0.05 mm | Lot Batch 20210716A:Width: S: 79 | Passed |
| ASTM D6319-19 (Physical Properties) | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Aging:Tensile Strength: ≥14MpaUltimate Elongation: ≥500%After Aging:Tensile Strength: ≥14MpaUltimate Elongation: ≥400% | For all three lots:Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500%After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Passed |
| ASTM D6319-19 (ASTM D5151-11) (Freedom from Holes) | To determine the holes in the gloves | AQL 2.5 | For all three lots: Pass at AQL 2.5 | Passed |
| ASTM D6319-19 (ASTM D6124-11) (Residual Powder) | To determine the residual powder in the gloves | < 2.0 mg/glove | Lot Batch 20210716A: 0.12 mg/gloveLot Batch 20210719A: 0.15 mg/gloveLot Batch 20210721C: 0.21 mg/glove | Passed |
| ISO 10993-10 (Skin Irritation) | To evaluate the potential intracutaneous reactivity caused by intracutaneously inject the extract to rabbits | Under the conditions of study not an irritation | Under the conditions of study not an irritation | Passed |
| ISO 10993-10 (Skin Sensitization) | To determine the skin sensitization potential in guinea pigs | Under the conditions of the study not a sensitization | Under the conditions of the study not a sensitization | Passed |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | The test item was evaluated for acute systemic toxicity in ICR mouse | Under the conditions of the study no systemic toxicity | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document provides information on three lot batches used for non-clinical performance testing:
- Lot Batch: 20210716A
- Lot Batch: 20210719A
- Lot Batch: 20210721C
The specific number of gloves sampled from each lot for each test (e.g., number of gloves for width/length, number of gloves for tensile strength, number of gloves for freedom from holes test to meet AQL 2.5) is not explicitly stated in the provided text. The data provenance is industrial testing of manufacturer's product, consistent with regulatory submissions for medical devices. The country of origin of the data is not explicitly stated, but the manufacturer is Guangdong Jiali Pharmaceutical Co.,Ltd in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes non-clinical performance testing (physical, chemical, and biocompatibility tests) of a medical device (nitrile examination gloves), not a study involving expert interpretation or medical imaging analysis. The "ground truth" for these tests is established by standardized laboratory methods and measurements according to ASTM and ISO standards.
4. Adjudication Method for the Test Set
This is not applicable as the study involves standardized physical and biocompatibility testing with objective pass/fail criteria, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers evaluate cases with and without AI assistance. This document describes the performance of examination gloves, which is not a diagnostic device.
6. Standalone Performance Study
Yes, a standalone study was done. The document focuses on the performance of the "Medical nitrile examination gloves" (JL001) itself against established international standards (ASTM and ISO). The device's performance was evaluated independently without human-in-the-loop interaction in a diagnostic sense.
7. Type of Ground Truth Used
The ground truth used for the non-clinical performance tests is based on established international standards and objective measurements:
- For physical properties (width, length, thickness, tensile strength, elongation, residual powder, freedom from holes): Adherence to specific quantitative thresholds defined in ASTM D6319-19 and referenced standards like ASTM D5151-11 and ASTM D6124-11.
- For biocompatibility: The biological response (irritation, sensitization, systemic toxicity) observed in animal models, evaluated against criteria defined in ISO 10993-10 and ISO 10993-11:2017.
8. Sample Size for the Training Set
This information is not applicable. The device described is a physical medical device (examination gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1