(98 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
Here's the breakdown of the acceptance criteria and study information based on the provided text, focused on the aspects typically used to describe medical device performance studies:
Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd. Disposable Powder Free Vinyl Exam Glove Yellow Color
This 510(k) summary primarily addresses the substantial equivalence of a disposable medical glove to a predicate device, focusing on material and physical integrity rather than a complex AI or diagnostic performance study. As such, the typical metrics for diagnostic device performance (e.g., sensitivity, specificity, AUC) are not applicable. Instead, the acceptance criteria relate to compliance with established ASTM standards and FDA requirements for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Performance Metric | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing (ASTM D5250-06) | Meets requirements for physical properties and dimensions. | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0." |
| Watertight Test (ASTM D-5151-06) | Watertight integrity (Pinhole detection). | "The FDA 1000 ml Watertight Test based on ASTM D-5151-06 was also conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements." |
| Primary Skin Irritation | Absence of primary skin irritant reactions. | "Primary Skin irritation... testing was conducted with results showing no primary skin irritant... reactions." |
| Skin Sensitization (allergic contact dermatitis) | Absence of sensitization reactions. | "Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no... sensitization reactions." |
| Residual Powder Test (ASTM D6124-06 for starch) | Powder content for "powder-free" claim (≤ 2 mg/glove). | "A residual Powder test that based on ASTM D6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per gloves)." |
| Biocompatibility | Satisfies biocompatibility requirements. | "meets... biocompatibility requirements" (implied by skin irritation/sensitization tests and general compliance). |
| Labeling Claims | Consistency with regulatory guidelines. | "meets... labeling claims" |
2. Sample Size Used for the Test Set and Data Provenance
The document provides specific sample sizes and inspection levels for certain tests:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Exact numerical sample size not specified, but refers to a standard sampling plan).
- Watertight Test: AQL 2.5, Inspection level I. (Exact numerical sample size not specified, but refers to a standard sampling plan).
- Skin irritation and Sensitization testing: Sample size not specified.
- Residual Powder Test: Sample size not specified.
The data provenance is the manufacturer, Xuzhou Full Sun Medical Products Ltd., in Jiangsu Province, China. The studies are prospective in the sense that they are performed on the manufactured product to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a Class I medical device (patient examination glove), and the compliance is assessed through standardized physical, chemical, and biological tests, not through expert interpretation of medical images or diagnostic data. Therefore, "ground truth" as typically defined for AI or diagnostic devices is not established by a panel of experts. The standards themselves define the "ground truth" for acceptable performance.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements or established biological assays, not subjective assessments requiring 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 is not a diagnostic device or an AI-powered system that involves human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The tests performed are standalone in the sense that they assess the device's inherent properties.
7. The Type of Ground Truth Used
The "ground truth" is defined by adherence to accepted industry standards and regulatory requirements. This includes:
- ASTM Standard D5250-06: For physical and dimensional properties of vinyl examination gloves.
- ASTM Standard D-5151-06: For pinhole detection in medical gloves (watertight test).
- ASTM Standard D6124-06: For residual powder content.
- Biocompatibility principles: Demonstrated through skin irritation and sensitization tests.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, 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.