(22 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-5250-06.
The provided text describes the regulatory submission for Powder Free Vinyl Patient Examination Gloves. It details the product's characteristics, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D-5250-06 (Physical and Dimensions) | Meets requirements |
| FDA 1000 ml Water Fill Test (AQL 2.5, Inspection Level I) | Meets requirements |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions |
| ASTM D-6124-06 (Residual Powder for "powder-free" claim) | No more than 2 mg powder per glove |
2. Sample size used for the test set and the data provenance
- ASTM D-5250-06: Inspection level S-2, AQL 4.0. The specific sample size is not explicitly stated but is implicitly defined by the AQL (Acceptable Quality Limit) standard.
- FDA 1000 ml Water Fill Test: Inspection level I, AQL 2.5. The specific sample size is not explicitly stated but is implicitly defined by the AQL standard.
- Primary Skin Irritation and Skin Sensitization: The sample size for these biocompatibility tests is not mentioned.
- Residual Powder Test (ASTM D-6124-06): The sample size for this test is not mentioned.
- Data Provenance: The data appears to be from non-clinical laboratory testing performed by or for the manufacturer, Hong Di Plastic Products Co., Ltd., which is based in Hebei, China. The text does not specify retrospective or prospective data collection but implies these were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are non-clinical and rely on established ASTM standards and FDA test methods, not on expert human interpretation for "ground truth" in the way, for example, a diagnostic imaging study would.
4. Adjudication method for the test set
Not applicable. The tests performed are objective, quantitative, or standard qualitative assessments (e.g., pass/fail for irritation), not subjective assessments requiring adjudication by multiple experts.
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 patient examination glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (a glove), not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance claims is based on established industry standards (ASTM) and regulatory test methods (FDA 1000 ml Water Fill Test, biocompatibility testing guidelines). For instance, the "ground truth" for pinhole detection is defined by the FDA 1000 ml Water Fill Test's criteria, and for mechanical properties, it's defined by ASTM D-5250-06. For biocompatibility, it's defined by the absence of specific adverse reactions.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.