(122 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, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
Here's a summary of the acceptance criteria and the study details for the Hongze Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard) | Reported Device Performance/Findings |
|---|---|---|
| Physical and Dimensions Testing | ASTM D 6319-00a (2005)e1 (Inspection level S-2, AQL 4.0) | All testing meets requirements. |
| Pinhole Detection | FDA 1000 ml. Water Fill Test (AQL 2.5, inspection level I) | Meets requirements. |
| Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions. |
| Skin Sensitization | No sensitization reactions (allergic contact dermatitis) | No sensitization reactions. |
| Residual Powder | No more than 2 mg powder per glove (ASTM D 6124-06) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility | Applicable 21 CFR references (implied by no skin irritation/sensitization) | Meets biocompatibility requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, it references:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
- Pinhole Detection (FDA 1000 ml. Water Fill Test): AQL 2.5, inspection level I.
The data provenance is not explicitly stated as "country of origin" but the submitting company is "Hongze Plastic Technology Co., Ltd. West District of Shenze Industrial Zone, Fuqian West Road, Shenze County, Shijiazhuang, Hebei, China". The studies are presented as non-clinical tests performed by the manufacturer to demonstrate substantial equivalence, implying they were conducted after the device's creation (retrospective to the submission, but likely prospective tests during manufacturing/quality control).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a patient examination glove and the testing involves objective physical, chemical, and biological performance criteria against established standards, not interpretation by medical experts.
4. Adjudication Method for the Test Set
This is not applicable. The tests are objective measurements against defined standards (e.g., AQL levels for physical properties, specific thresholds for irritancy). There is no "ground truth" established by human interpretation that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging or interpretation devices where human performance with and without AI assistance is evaluated. This is not relevant for a patient examination glove.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is a physical product (a glove), not an algorithm or AI system. The tests performed are inherent to the product's physical and biological properties.
7. Type of Ground Truth Used
The "ground truth" for the performance tests is based on:
- Established ASTM Standards: D 6319-00a (2005)e1 for physical and dimensional properties, and D 6124-06 for residual powder.
- FDA Requirements: Specifically for the 1000 ml Water Fill Test for pinholes.
- Biocompatibility Testing Protocols: To determine if there are primary skin irritant or sensitization reactions.
8. Sample Size for the Training Set
This is not applicable. The device is not a machine learning model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is 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.