(40 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves. 80 LYZ. and meets all requirements of ASTM standard D-5250-00E4.
The document is a 510(k) Pre-market Notification for a medical device: Ever Light Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves-Powdered. It focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI studies, multi-reader multi-case studies, and ground truth for AI training and testing are not applicable.
Here's the information that can be extracted from the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Conforms to ASTM D-5250-00E4 | Meets all requirements for physical and dimension testing. | Non-Clinical, based on ASTM D-5250-00E4 |
| FDA 1000 ml. Water Fill Test requirements (AQL 2.5, inspection level I) | Meets these requirements. | Non-Clinical, FDA 1000 ml. Water Fill Test |
| No primary skin irritant reactions | Results showed no primary skin irritant reactions. | Non-Clinical, Primary Skin Irritation testing |
| No sensitization reactions (allergic contact dermatitis) | Results showed no sensitization reactions. | Non-Clinical, Skin Sensitization testing |
| Residual Powder Test (no more than 10mg/dm2) based on ASTM D-6124-01 | Meets the "powdered" claims (implied to be ≤ 10mg/dm2). | Non-Clinical, Residual Powder Test based on ASTM D-6124-01 |
| Biocompatibility requirements | Meets biocompatibility requirements. | Non-Clinical (implied by skin irritation/sensitization tests) |
| Labeling claims | Meets labeling claims. | Non-Clinical |
Study Details
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Sample size used for the test set and the data provenance:
- For ASTM D-5250-00E4 compliance and FDA Water Fill Test, inspection levels, and AQL (Acceptable Quality Level) are mentioned:
- ASTM testing: Inspection level S-2, AQL 4.0
- Water Fill Test: AQL 2.5, inspection level I
- Specific raw sample sizes (number of gloves) are not explicitly stated, but these AQL and inspection levels define the sampling plan used.
- Data Provenance: The device is manufactured by Ever Light Products Co., Ltd. in Hebei, China. The testing was performed by them or on their behalf. The data is retrospective in the sense that it's performed on manufactured batches of gloves.
- For ASTM D-5250-00E4 compliance and FDA Water Fill Test, inspection levels, and AQL (Acceptable Quality Level) are mentioned:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device testing, not an AI evaluation requiring human expert ground truth.
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Adjudication method for the test set:
- Not applicable. Results are based on objective physical and chemical tests against defined standards.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document describes a physical medical device (gloves), not an AI-powered diagnostic or assistive technology.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document describes a physical medical device (gloves), not an AI algorithm.
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The type of ground truth used:
- Objective physical and chemical standards: The "ground truth" for the performance of the gloves is established by predefined standardized tests and limits (e.g., ASTM D-5250-00E4, FDA 1000 ml. Water Fill Test requirements, ASTM D-6124-01 for residual powder, and biocompatibility standards measured by irritation/sensitization tests).
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The sample size for the training set:
- Not applicable. This is not an AI study requiring a training set. The "training" in a manufacturing context would refer to process parameters and quality control, not data used to train an algorithm.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.