(90 days)
A patient examination glove is disposable non-sterile 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 is a 510(k) summary for a medical device: "Shijiazhuang Great Vision Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves". This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with AI assistance. As such, many of the requested categories for AI-assisted device studies are not applicable or cannot be extracted from this document.
Here's the information that can be extracted or deduced from the provided text, and noted where information is not applicable (N/A) for this type of device and submission:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | Meets requirements of ASTM standard D-5250-06e1. |
| Pinholes (Water Fill Test): | FDA 1000 ml. Water Fill Test conducted with samplings of AQL 2.5, inspection level I, meets requirements. |
| Primary Skin Irritation: | Results showed no primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis): | Results showed no sensitization reactions. |
| Residual Powder Content: | Meets "powder-free" claims (contains no more than 2 mg powder per glove), based on ASTM D-6124-06. |
| Biocompatibility: | Meets biocompatibility requirements. |
| Labeling Claims: | Meets labeling claims (no special claims, not hypoallergenic). |
| Overall Safety and Effectiveness: | As safe, as effective, and performs as well as or better than the predicate device. |
Study Details
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Sample size used for the test set and the data provenance:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. No specific number of gloves tested is provided.
- Pinhole (Water Fill Test): AQL 2.5, inspection level I. No specific number of gloves tested is provided.
- Primary Skin Irritation and Skin Sensitization: Not specified in terms of number of subjects or samples.
- Residual Powder Test: Not specified in terms of number of gloves tested.
- Data Provenance: Not explicitly stated, but the testing was performed by "Shijiazhuang Great Vision Plastic Products Co., Ltd." in China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a submission for an examination glove, not an AI-assisted diagnostic device requiring expert interpretation of medical images or data. The testing involves standardized quality control and biocompatibility tests.
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Adjudication method for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are typical for studies involving human interpretation of medical data (e.g., radiology reads) where there might be disagreement among experts. For glove testing, the criteria are objective and defined by ASTM standards and FDA tests.
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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:
- N/A. This is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is not an AI-assisted device.
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The type of ground truth used:
- The "ground truth" for this device's performance evaluation is established through adherence to recognized industry standards (ASTM D-5250-06e1 for physical properties, ASTM D-6124-06 for residual powder) and FDA-specific testing protocols (1000 ml. Water Fill Test), as well as biocompatibility testing standards. These are objective measures and pass/fail criteria defined by these standards.
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The sample size for the training set:
- N/A. This is not an AI-assisted device that requires a training set. The descriptions relate to manufacturing quality control and product testing.
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How the ground truth for the training set was established:
- N/A. No training set is applicable for this device.
§ 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.