(108 days)
Nitrile disposable examination gloves are non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.
This document describes the performance testing and acceptance criteria for Nitrile disposable examination gloves. It is important to note that this is a physical medical device (gloves), not an AI/software-based medical device. Therefore, many of the requested criteria in your prompt (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable to this type of device.
Here's the information extracted from the provided text, focusing on the relevant criteria for a physical device:
1. Table of Acceptance Criteria and Reported Device Performance
The performance data is primarily presented in a comparative table against ASTM standards.
| Test Methodology (Standard) | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions | Length: ≥220 mm (S), ≥230 mm (M, L, XL) | Pass |
| Width: S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | Pass | ||
| Thickness Finger: ≥0.05 mm | Pass | ||
| Thickness Palm: ≥0.05 mm | Pass | ||
| ASTM D6319-19 | Physical Properties | Before Aging: Tensile ≥14 Mpa; Elongation ≥ 500% | Pass |
| After Aging: Tensile ≥14 Mpa; Elongation ≥ 400% | Pass | ||
| ASTM D6319-19 (in acc. with ASTM D5151-19) | Watertightness Test for detection of holes | Batch size=35000, sample 125, ≤ 7 defects (AQL 2.5) | Pass |
| ASTM D6319-19 (in acc. with D6124-06(2017)) | Powder Residual | ≤ 2 (mg/glove) | Pass |
| ISO 10993-10: 2010 | Biocompatibility (Skin Irritation Test) | Non-irritation | Passes (non-irritation) |
| ISO 10993-10: 2010 | Biocompatibility (Skin Sensitization Test) | Non-sensitization | Passes (non-sensitization) |
| ISO 10993-11: 2017 | Biocompatibility (Acute Systemic Toxicity Test) | Non-acute systemic toxicity | Passes (non-acute systemic toxicity) |
| ASTM D7161-16 | Shelf Life | Determined a 3-year shelf life. (Specific numerical acceptance criteria not explicitly stated, but the 'Different*1 analysis' implies successful determination) | 3 years (Determined) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the Watertightness Test (detection of holes), the sample size is explicitly stated: 125 samples for a batch size of 35,000.
- For other tests (Physical Dimensions, Physical Properties, Powder Residual, Biocompatibility), specific sample sizes are not detailed in the provided document. The document refers to meeting ASTM and ISO standards, which would implicitly define testing sample sizes.
- Data Provenance: The tests are described as "bench testing" and "non-clinical performance data." The company performing the tests is XINGYU MEDICAL TECH CO.,LTD., located in China. The data is retrospective in the context of the 510(k) submission, meaning the tests were completed prior to submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device, and performance is measured against established international standards (ASTM, ISO) for physical and chemical properties, not by human expert interpretation of data or images. The "ground truth" is defined by the technical specifications and test methodologies within these standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device, testing is quantitative and follows specific, standardized protocols. There is no human adjudication process involved in the interpretation of physical test results. Results are either "Pass" or "Fail" based on whether they meet the numerical acceptance criteria of the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. This is a physical medical device (gloves), so an MRMC study is not applicable. The document explicitly states: "Clinical data is not needed to demonstrate the performance or safety of the subject glove as compared to the predicate device or applicable standards."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to AI algorithm performance. This product is a physical glove, not an algorithm. The testing described is "standalone" in the sense that it's testing the inherent properties of the glove itself against defined standards.
7. The Type of Ground Truth Used
- The ground truth for this device's performance relies on established international consensus standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06(2017), ISO 10993-10: 2010, ISO 10993-11: 2017, ASTM D7161-16). These standards define the acceptable physical dimensions, mechanical properties (tensile strength, elongation), barrier integrity (pinholes), chemical properties (powder residual), and biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable. This refers to AI algorithm training data. This product is a physical glove and does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for a physical device like this, there is no ground truth established in this context.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove 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. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.