(62 days)
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 Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
The provided text describes the 510(k) summary for the "Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves." This submission is for a Class I medical device (patient examination glove), which is a low-risk device. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards, rather than complex clinical studies involving human readers or extensive ground truth establishment typical of AI/CADe devices.
Here's an analysis of the provided text against your requested criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Set by Standard) | Reported Device Performance (from Hong Di Gloves) |
|---|---|
| Conformance to ASTM D-5250-06e1 (Physical and dimensions testing) | All testing meets requirements for physical and dimensions testing. |
| FDA 1000 ml. Water Fill Test (AQL 2.5, inspection level I) | Test conducted with samplings of AQL 2.5, inspection level I, meeting these requirements (pinhole FDA requirements). |
| Primary Skin Irritation Test | Results show no primary skin irritant reactions. |
| Skin Sensitization Test (allergic contact dermatitis) | Results show no sensitization reactions. |
| Residual Powder Test (ASTM D-6124-06) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility requirements | Meets biocompatibility requirements (implied by skin irritation/sensitization tests). |
| Labeling Claims | Meets labeling claims (no special claims, not hypoallergenic). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For ASTM D-5250-06e1 (Physical and dimensions testing): Inspection level S-2, AQL 4.0. (Specific sample number not given, but refers to a standard sampling plan).
- For FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I. (Specific sample number not given, but refers to a standard sampling plan).
- For Primary Skin Irritation and Skin Sensitization: Not specified.
- For Residual Powder Test: Not specified (but based on ASTM D-6124-06).
- Data Provenance: Not explicitly stated, but the tests were performed by the manufacturer, Hong Di Plastic Products Co., Ltd., which is located in China. The data would be prospective as it's part of the device's validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a patient examination glove, and its performance evaluation relies on objective, standardized physical and chemical tests, not on expert interpretation of medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective and quantitative (e.g., measuring dimensions, water fill, powder count, skin reaction), not subject to expert adjudication.
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 device is a glove and does not involve AI or human readers for its intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective measurements and adherence to recognized industry standards (ASTM) and regulatory requirements (FDA). For example:
- Physical properties (tensile strength, elongation, dimensions) are measured against ASTM D-5250-06e1 specifications.
- Pinhole integrity is assessed by the FDA 1000 ml Water Fill Test.
- Biocompatibility is assessed through in-vitro/in-vivo tests for irritation and sensitization.
- Powder content is measured against ASTM D-6124-06.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that context. The manufacturing process is controlled to meet the specifications.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.