(76 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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 800,6250, Powder-Free Vinvl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D5250-92 (all requirements) | Meets all requirements for Physical and Dimensions Testing, Inspection Level S-2, AQL 4.0 |
| FDA 1000 ml. Water Fill Test (pinhole defect) | Meets requirements for AQL 2.5, Inspection Level S-4 |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| USP Iodine Test for Starch (powder-free claim) | Revealed passing results |
| Applicable 21 CFR references | Conforms fully |
| Biocompatibility requirements | Meets requirements (implied by skin irritation/sensitization testing) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0 (The exact number of gloves tested is not specified but is a standard sampling plan based on lot size).
- FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5 (The exact number of gloves tested is not specified but is a standard sampling plan based on lot size).
- Primary Skin Irritation and Skin Sensitization: Not specified, but generally involves human subjects or animal models.
- USP Iodine Test: Not specified, but performed during finished inspection.
- Data Provenance: Not explicitly stated, but the submission is from a company in P.R. China, implying the testing likely occurred there or at a contract lab. The studies would be considered prospective as they were conducted specifically to demonstrate compliance for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of medical device (patient examination gloves) does not typically involve "experts" in the sense of clinicians establishing ground truth for performance, as would be the case for diagnostic imaging or AI devices. The ground truth is established by standardized testing methods and regulatory limits (e.g., maximum acceptable pinhole rate, absence of irritation).
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective, standardized laboratory and physical tests, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance might improve their performance. This device is a physical barrier protection, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical product, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance (e.g., pinhole rate, tensile strength) is inherently "standalone" in that it's measured directly from the product.
7. The Type of Ground Truth Used:
The ground truth for this device is based on established industry standards and regulatory requirements, specifically:
- ASTM Standard D5250-92: Defines physical properties, dimensions, and testing methods for vinyl patient examination gloves.
- FDA 1000 ml. Water Fill Test: A regulatory standard for assessing pinhole defects.
- Biocompatibility Standards: Implicitly covered by Primary Skin Irritation and Skin Sensitization testing, aiming for a lack of adverse biological reactions.
- USP Iodine Test for Starch: A standard method to verify "powder-free" claims.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI algorithm, so there is no "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.