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510(k) Data Aggregation
(96 days)
The Disposable Nitrile Medical Powder-free Glove 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 powder free nitrile 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.
This document is a 510(k) Premarket Notification for a Disposable Nitrile Medical Powder-free Glove. It does not describe an AI/ML-driven medical device. Therefore, the request to describe acceptance criteria and a study proving an AI/ML device meets those criteria cannot be fully answered from this document.
However, I can extract information related to the non-clinical performance testing conducted for this medical device (the glove), which serves a similar purpose to acceptance criteria and study results for verifying performance against established benchmarks.
Here's an adaptation of the requested format focusing on the non-clinical performance of the medical glove, as an AI/ML study was not conducted:
Device: Disposable Nitrile Medical Powder-free Glove (non-AI/ML device)
This document does not pertain to an AI/ML medical device. Therefore, information regarding "Multi-Reader Multi-Case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "effect size of human readers improving with AI," "sample size for training set," and "how ground truth for training set was established" is not applicable.
The following tables and information describe the acceptance criteria and the non-clinical testing proving the device meets these criteria.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥220; M/L/XL: ≥230Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Length (mm): > 230/PassWidth (mm): S: 83-86 /Pass; M: 94-98/ Pass; L: 101-103/ Pass; XL:113-115/ PassThickness (mm): Finger: 0.13-0.15/Pass; Palm: 0.09/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 << 2.0mg | 0.21-0.24mg/Pass |
| ASTM D412 | Physical Properties | Before Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥500%After Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥400% | Before Aging: 14.3-20.7MPa/Pass; 500-699%/PassAfter Aging: 14.0-17.8MPa/Pass; 490-569%/Pass |
| ISO 10993-11 | Cytotoxicity (Systemic Toxicity) | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each test, but it provides specific values for some tests:
- Watertightness Test (ASTM D5151): Tested 125 units (0/125/Pass implies a sample size of 125).
- For other tests like dimensions, powder content, and physical properties, specific sample sizes are not detailed but are assumed to be in compliance with the respective ASTM and ISO standards.
- Data Provenance: Not specified, but generally, these non-clinical tests are conducted by the manufacturer or a contracted lab in the country of origin (China, in this case). The data is retrospective in the sense that it's gathered specifically for the submission.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is a physical medical device (glove), not an AI/ML device requiring expert interpretation for ground truth. Ground truth is established through standardized physical, chemical, and biological testing methods.
4. Adjudication Method for the Test Set
- Not Applicable. As this is not an AI/ML device involving human interpretation, no adjudication method is relevant. Test results are objective measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is a physical medical device, not an AI/ML diagnostic or assistive tool.
6. Standalone Performance (Algorithm Only)
- Not Applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
- Objective Measurement against Industry Standards: The ground truth for this device's performance is established by standardized test methods from organizations like ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards define the physical, chemical, and biological properties expected of such a device. For example, "Tensile Strength ≥14MPa" is an objective ground truth defined by ASTM D412.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is a physical medical device.
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