(35 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 purposes 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, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00€4.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Performance Metric | Reported Device Performance |
|---|---|---|
| ASTM D5250-00€4 (General) | All requirements | Meets all requirements of ASTM Standard D5250-00€4 |
| FDA 1000 ml. Water Fill Test based on ASTM D-5151-99 | AQL | Meets requirements at AQL 2.5, Inspection Level I |
| Biocompatibility (Primary Skin Irritation) | Irritation | No primary skin irritant reactions |
| Biocompatibility (Skin Sensitization) | Sensitization | No sensitization reactions |
| Powder-free Claim (ASTM D6124-01 for Starch) | Residual Powder | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample Size Used for the Test Set and Data Provenance
The document specifies the following for the non-clinical tests:
- ASTM D5250-00€4 (Physical and Dimensions Testing): Inspection Level S-2, AQL 4.0. The exact sample size is not explicitly stated but is implicitly defined by the AQL (Acceptable Quality Level) and inspection level, which are statistical sampling plans.
- FDA 1000 ml. Water Fill Test based on ASTM D-5151-99: AQL 2.5, Inspection Level I. Again, the exact sample size is not explicitly stated but is defined by the AQL and inspection level.
- Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biocompatibility tests is not provided in the document.
- Residual Powder Test: The sample size for this test is not provided.
Data Provenance: The tests were conducted by Grand Work Plastics Products Co., Ltd. in China. The data's provenance is therefore retrospective (tests conducted on manufactured products) and originates from China.
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 physical medical glove, and the "ground truth" for its performance is established through objective, standardized physical and chemical tests, not through expert human interpretation of data for diagnostic purposes.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as #3. The tests have predefined pass/fail criteria based on accepted standards.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices where human readers interpret medical images or data. The device in question is a physical glove, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study (in the context of an algorithm) was not done. This device is not an algorithm or AI product. Its performance is measured through direct laboratory testing.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Objective, Pre-defined Standards and Specifications: Specifically, ASTM D5250-00€4, ASTM D-5151-99, and ASTM D6124-01. These standards define the acceptable physical properties, barrier integrity (pinhole), and powder content.
- Biocompatibility Testing Protocols: Which assess the biological response to the material.
8. The Sample Size for the Training Set
This refers to the sample size of data used to train a machine learning model. Since the device is a physical product and not an AI/ML algorithm, a "training set" in this context is not applicable. The manufacturing process for the gloves would involve quality control and process validation, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm associated with this device, this question is not applicable.
§ 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.