(26 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 document describes the testing and acceptance criteria for Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powder Free (Yellow) Vinyl Patient Examination Gloves.
Here is the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Dimensions | ASTM D-5250-00E4 | Meets all requirements (specifics not detailed in document but implied by standard) | Meets all requirements |
| Integrity (Pinhole) | FDA 1000 ml. Water Fill Test | AQL 2.5, Inspection Level I | Meets these requirements |
| Biocompatibility | Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions |
| Biocompatibility | Skin Sensitization (allergic contact dermatitis) | No sensitization reactions | No sensitization reactions |
| Powder Residue | Residual Powder Test (based on ASTM D-6124-06) | No more than 2 mg powder per glove | Meets "powder-free" claims (i.e., less than 2 mg powder per glove) |
| Quality System | General/Manufacturing | Inspection Level S-2, AQL 4.0 | Meets these requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Pinhole (Water Fill Test): "samplings of AQL 2.5, inspection level I" - The exact sample size is not explicitly stated, but it would be determined by the AQL and inspection level, referencing ISO 2859-1 or a similar standard.
- Physical Dimensions & Quality System: "Inspection level S-2, AQL 4.0" - Similar to the pinhole test, the exact sample size is not explicitly stated.
- Biocompatibility & Residual Powder: Sample sizes were not specified in the provided document.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd., in China. The data would be considered retrospective as it was conducted on finished products for regulatory submission.
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 medical glove, and its performance is evaluated against engineering standards and material properties, not through expert human interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against established standards (e.g., water fill for pinholes, chemical analysis for powder, physical measurements for dimensions). No human adjudication of differing interpretations is required.
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 typically used for diagnostic devices that involve human interpretation of results (e.g., radiology images), not for a medical device like an examination glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described is effectively standalone performance. The device's characteristics (physical properties, absence of pinholes, biocompatibility, powder residue) were measured directly without human intervention or interpretation that would alter the test outcome.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Industry Standards: Adherence to ASTM standard D-5250-00E4 for physical and dimensional characteristics, and ASTM D-6124-06 for residual powder.
- Regulatory Requirements: Adherence to FDA's 1000 ml. Water Fill Test for pinholes, and biocompatibility testing requirements.
- Objective Measurements: These standards and requirements define objective, measurable performance criteria.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The product is manufactured and then tested for compliance.
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.