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510(k) Data Aggregation
(55 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 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 Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.
The provided document is a 510(k) summary for Shijiazhuang Great Vision Plastics Products Co., Ltd. Powder Free (Blue) Nitrile Patient Examination Gloves. This product is a Medical Device, not an AI/ML device. Therefore, the specific information requested about acceptance criteria, study details, and AI/ML specific aspects (like multi-reader multi-case studies, standalone performance, training/test sets, and ground truth establishment) is not applicable to this submission.
However, I can extract the acceptance criteria and the results of the non-clinical tests performed to demonstrate substantial equivalence, which is the analogous information for this type of device.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test Performed | Standard / Requirement | Reported Device Performance / Result |
|---|---|---|
| Physical and Dimensions Testing (for glove production) | ASTM-D-6319-00a1, Inspection Level S-2, AQL 4.0 | Meets all requirements |
| FDA 1000 mL Water Fill Test (for pinholes) | AQL 2.5, Inspection Level G-1 | Meets these requirements |
| Primary Skin Irritation | N/A (implied standard for biocompatibility) | No primary skin irritant |
| Skin Sensitization (allergic contact dermatitis) | N/A (implied standard for biocompatibility) | No sensitization reactions |
| Residual Powder Test (for "powder-free" claim) | ASTM D6124-01 (for Starch), < 2 mg powder per glove | Meets "powder-free" claims |
| Biocompatibility (based on Primary Skin Irritation/Sensitization) | N/A (implied standard for medical devices) | Meets requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact sample size is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) and inspection level. Data provenance is implied to be from the manufacturer (Shijiazhuang Great Vision Plastics Products Co., Ltd.) in P.R. China, based on the submission. This would be prospective testing as part of product manufacturing and quality control.
- FDA 1000 mL Water Fill Test: AQL 2.5, Inspection Level G-1. Similar to above, the exact sample size is not explicitly stated but determined by AQL and inspection level. Data provenance is implied from the manufacturer, prospective testing.
- Primary Skin Irritation and Skin Sensitization: The sample size for these tests is not specified in the summary. Data provenance is implied to be from testing conducted by or for the manufacturer. This would be prospective.
- Residual Powder Test: The sample size is not specified, but the test is conducted "at finished inspection," implying routine quality control. Data provenance from the manufacturer, prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical product (examination gloves), and its performance is evaluated through standardized physical, chemical, and biological tests, not by expert interpretation or ground truth derived from expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for interpretive tasks where multiple experts' opinions need to be reconciled, such as in image analysis or diagnostic assessments. For physical product testing, results are objective measurements against defined standards.
5. 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 is not an AI/ML device, and no human reader studies are relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective, quantitative measurements and qualitative biological assessments against established ASTM standards and FDA requirements. For example, the presence of pinholes is objectively measured using the water fill test, and biocompatibility is assessed through standardized irritation/sensitization assays.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not involve a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device and does not involve a training set or its associated ground truth establishment.
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