(280 days)
A patient examination glove is disposable device intended for medical a 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, Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
The provided document describes the acceptance criteria and the study performed for a medical device: Better Care Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| ASTM D-5250-06e1 (Physical and Dimensions Testing) | All testing meets requirements for physical and dimensions testing. |
| FDA 1000 ml. Water Fill Test | Meets requirements (AQL 2.5, inspection level I). |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions. |
| Residual Powder Test (ASTM D-6124-06) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Pinhole FDA requirements | Meets pinhole FDA requirements. |
| Biocompatibility requirements | Meets biocompatibility requirements. |
| Labeling claims | Meets labeling claims. |
2. Sample Size Used for the Test Set and Data Provenance
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ASTM D-5250-06e1 Testing: The document states "Inspection level S-2, AQL 4.0" for physical and dimensions testing. AQL (Acceptable Quality Limit) and inspection level are metrics for sampling, but the precise sample size in numbers is not explicitly stated.
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FDA 1000 ml. Water Fill Test: "Samplings of AQL 2.5, inspection level I" were conducted. Again, a precise numerical sample size is not provided, but these metrics define the sampling plan.
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Primary Skin Irritation and Skin Sensitization: The sample size for these tests is not specified in the document.
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Residual Powder Test: The sample size for this test is not specified.
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Data Provenance: The studies were performed by Better Care Plastic Products Co., Ltd. for their product. The location of the company is Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province 050000 (China). The data is retrospective as it was collected before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the tests performed are primarily laboratory-based performance and safety tests for examination gloves, not diagnostic studies requiring expert review of medical images or data. Ground truth here refers to the objective results of the specified physical, chemical, and biological tests.
4. Adjudication Method for the Test Set
- This is not applicable. The tests are objective and performed according to established ASTM standards and FDA protocols (e.g., water fill test). There is no "adjudication" in the sense of reconciling differing expert opinions, as the results are determined by the test procedures themselves.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- This is not applicable. The device is an examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- This is not applicable. The device is an examination glove and does not involve any algorithms or AI for standalone performance evaluation.
7. The Type of Ground Truth Used
- The ground truth for this device is based on objective measurements and laboratory test results adhering to recognized standards (ASTM D-5250-06e1, ASTM D-6124-06) and regulatory requirements (FDA 1000 ml. Water Fill Test, biocompatibility assessments). It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense. It's the inherent physical and chemical properties of the glove.
8. The Sample Size for the Training Set
- This is not applicable. The device is a physical medical product (examination gloves) that undergoes testing based on established standards, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the same reason as point 8.
§ 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.