(63 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 and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00€4.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the medical device:
The provided document describes the 510(k) summary for "Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powdered (Yellow) Vinyl Patient Examination Gloves." This is a regulatory filing for a Class I medical device, which typically involves demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies in the same way a novel high-risk device would.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM-D-5250-00E4) | All testing meets requirements |
| Inspection level S-2, AQL 4.0 | All testing meets requirements |
| Pinhole FDA Requirements (FDA 1000 ml. Water Fill Test) | Meets requirements with AQL 2.5, inspection level I |
| Biocompatibility (Primary Skin Irritation) | No primary skin irritant reactions |
| Biocompatibility (Skin Sensitization / Allergic Contact Dermatitis) | No sensitization reactions |
| Residual Powder (ASTM D-6124-06) | Meets required claims (no more than 10mg/dm2) |
| Labeling | No special labeling claims; not claimed as hypoallergenic |
| Safety/Efficacy Issues | No safety/efficacy issues or new claims |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions specific inspection levels and AQLs (Acceptable Quality Levels) for certain tests, which imply statistical sampling.
- Pinhole FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I.
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
- Residual Powder Test: Based on ASTM D-6124-06.
The exact number of units sampled for each test is not explicitly stated as a single "sample size" in this document, but rather referred to by AQL and inspection levels, which are methods for determining sample size based on lot size in quality control.
Data Provenance: The tests were conducted on gloves produced by Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. in China. The study is inherently prospective in the sense that the manufacturer performs these tests as part of their quality control and regulatory submission for the specific device being produced to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No external "experts" were used to establish ground truth in the context of comparative clinical evaluation for the acceptance criteria listed.
- The nature of these acceptance criteria (physical properties, biocompatibility, pinhole integrity, residual powder) means that the "ground truth" is established by adherence to pre-defined ASTM standards and FDA test methods. The performance is measured against these objective standards.
- The tests themselves would have been conducted by technicians or laboratory personnel, but their qualifications are not detailed, nor are they "experts" establishing a ground truth in the sense of clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., images) and their disagreements need to be resolved to establish a consensus ground truth. For the physical and chemical tests described here, the results are objective measurements against established standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. This type of study is not relevant for patient examination gloves, which are assessed based on their physical properties, barrier integrity, and biocompatibility, not on their interpretive performance or human reader interaction with an AI system.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
Not applicable. This device is a physical product (gloves) and does not involve an algorithm or AI. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for these acceptance criteria is based on:
- External Standards and Test Methods: Primarily ASTM standards (D-5250-00E4, D-6124-06) and FDA test methods (e.g., 1000 ml. Water Fill Test).
- Objective Measurements: These standards define measurable properties (e.g., tensile strength, elongation, dimensions, pinhole count, residual powder quantity).
- Biocompatibility Testing Protocols: Standardized animal or in-vitro tests for skin irritation and sensitization.
8. The Sample Size for the Training Set
Not applicable. This is a conventional medical device (gloves), not an AI/ML powered device. There is no "training set." The manufacturing process itself could be considered "trained" through quality control and adherence to standards over time, but not in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set 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.