(79 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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
This looks like a 510(k) premarket notification for disposable vinyl examination gloves, not an AI/ML medical device. Therefore, the questions about AI/ML specific criteria, study design, and performance metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable.
However, I can extract the acceptance criteria and the "study" (non-clinical tests in this context) that proves the device meets them, based on the provided text.
Here's an interpretation based on the document:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)
| Acceptance Criteria (Standard/Test) | Reported Device Performance | Comments |
|---|---|---|
| ASTM D-5250-00E4 (General Requirements) | Conforms fully to this standard | This encompasses physical and dimensional testing. |
| FDA 1000 mL Water Fill Test (Pinhole AQL) | AQL 2.5, Inspection Level I, meets requirements | This tests for pinholes/integrity, crucial for barrier protection. |
| Residual Powder Test (ASTM D-6124-06 for Starch) | Contains no more than 2 mg powder per glove | Meets "powder-free" claims. |
| Primary Skin Irritation Test | No primary skin irritant reactions | Biocompatibility testing. |
| Skin Sensitization Test (Allergic Contact Dermatitis) | No sensitization reactions | Biocompatibility testing. |
| 21 CFR references (Applicable) | Meets all applicable 21 CFR requirements | General regulatory compliance. |
2. Sample size used for the test set and the data provenance:
- Pinhole Testing (FDA 1000 ml Water Fill Test): "samplings of AQL 2.5, inspection level I". This indicates a specific sampling plan from an Acceptable Quality Level (AQL) standard, but the exact number of gloves tested is not explicitly stated.
- Physical and Dimensional Testing (ASTM-D-5250-00E4): "Inspection level S-2, AOL 4.0". Similar to above, this references an AQL sampling plan, but the exact sample size is not numerically provided.
- Residual Powder Test (ASTM D-6124-06): Not explicitly stated, but implies routine inspection.
- Biocompatibility (Primary Skin Irritation and Skin Sensitization): The exact number of subjects or samples used in these tests is not specified in the document.
- Data Provenance: The device is manufactured by "Super Safe Plastic Products Co., Ltd." in "Shijiazhuang, Hebei, China". The testing was performed by the manufacturer or a contracted lab to demonstrate compliance with US standards. The data is retrospective in the sense that the tests were completed before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is a physical medical device (gloves), not an AI/ML diagnostic or interpretive device. The "ground truth" is established through standardized physical, chemical, and biological tests.
4. Adjudication method for the test set:
- Not applicable for this type of device. Compliance is determined by objective measurements against established 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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
- The ground truth is based on objective measurements and standardized test methods as defined by ASTM standards (D-5250-00E4, D-6124-06) and FDA test protocols (1000 ml Water Fill Test), as well as biocompatibility testing standards. For example, for the "powder-free" claim, the ground truth is "no more than 2 mg powder per glove" as measured by the ASTM D-6124-06 method.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. There is no "training set" in the context of manufacturing and quality control for gloves; rather, there are manufacturing processes that are controlled to meet specifications.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML 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.