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510(k) Data Aggregation
(99 days)
Examination gloves -Type C (Nitrile gloves)
The Examination gloves-Type C (Nitrile gloves) 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.
The proposed device is one kind of patient examination glove made from nitrile rubber compounds. The typical characters of these examination gloves are blue color, single-layer, powder-free, non-sterilized, single-use, variable size (see table 2.). These examination gloves can be worn on the examiner's hands or fingers during a medical examination. In addition, it is for over-the-counter use and also for adult use only.
This document summarizes the acceptance criteria and performance data for Examination gloves - Type C (Nitrile gloves), as presented in the provided FDA 510(k) Premarket Notification.
1. Table of Acceptance Criteria and Reported Device Performance
| Standard / Test | Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5151-19 | Freedom from holes | No water leakage (0 pinhole) | 0 pinhole found |
| ASTM D6319-19 | Physical Dimension | Multi acceptance criteria refer to ASTM D6319 Clause 7.4- TABLE 2. | Meet requirements. (Specific values in Table 4) |
| ASTM D6319-19 | Tensile strength and Elongation | Multi acceptance criteria refer to ASTM D6319 Clause 7.5- TABLE 3. | Meet requirements. (Specific values in Table 5) |
| ASTM D6124-06 (Reapproved 2017) | Residual powder | $\leq$2.0 mg/glove | 0.10 mg/glove (before aging), |
| 0.12 mg/glove (after aging) | |||
| ISO 10993-10:2010 | Skin sensitization and irritation | No irritation and skin sensitization | No irritation and skin sensitization |
| ISO 10993-11:2017 | Systemic toxicity | No acute systemic toxicity | No acute systemic toxicity |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test within the "Non-Clinical Testing" section. However, the tests are conducted in conformance with recognized international and national standards (ASTM, ISO), which typically specify appropriate sample sizes and methodologies.
The provenance of the data is not explicitly stated in terms of country of origin, but it is derived from non-clinical laboratory testing performed by the manufacturer, Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., located in Nanchang City, Jiangxi Province, China. The data is retrospective, as it represents results from tests already performed on the finished device to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The device in question is a physical medical device (examination gloves), and the "ground truth" for its performance is established through objective, standardized laboratory tests (e.g., water leakage for pinholes, mechanical strength tests, chemical analysis for residual powder, and biological safety assessments). These are not typically assessed by human experts establishing a "ground truth" in the way, for example, a radiologist would for an AI image analysis system.
4. Adjudication Method for the Test Set
This information is not applicable. The tests performed are objective, quantitative measurements or qualitative observations (e.g., "no irritation") based on standardized protocols rather than subjective interpretations requiring adjudication among multiple human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This document pertains to non-AI-powered examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical product (examination gloves), not an algorithm or software requiring a standalone performance evaluation.
7. The Type of Ground Truth Used
The ground truth for the performance of the examination gloves is established through:
- Standardized Test Methods: Adherence to established industry standards like ASTM (e.g., D5151-19 for holes, D6319-19 for physical properties, D6124-06 for residual powder) and ISO (e.g., 10993-10 for irritation/sensitization, 10993-11 for systemic toxicity).
- Objective Measurements: Quantitative measurements (e.g., length, width, thickness, tensile strength, elongation, residual powder amount) with defined acceptable ranges.
- Biological Assessments: Standardized biological evaluations to determine irritation, sensitization, and systemic toxicity, with "no irritation," "no sensitization," and "no acute systemic toxicity" as the ground truth for biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. This device is an examination glove, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this device.
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