(19 days)
A 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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, structured to address your specific points:
This document describes the 510(k) submission for a Non-Sterile Powder-Free Blue Nitrile Patient Examination Glove. The information provided focuses on the device's conformance to established standards rather than clinical performance against specific disease conditions.
Acceptance Criteria and Device Performance
A specific table format for acceptance criteria and reported device performance is not explicitly provided in the document. However, the document outlines the standards the device meets and the relevant performance metrics.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D6319-00aE3 | Met all requirements. |
| Physical & Dimensions Testing | Met requirements for Inspection Level S-2, AQL 4.0. |
| FDA 1000 ml. Water Fill Test | Met requirements for AQL 2.5, Inspection Level G-1. |
| Primary Skin Irritation Test | No primary skin irritant reactions. |
| Skin Sensitization Test | No sensitization reactions (allergic contact dermatitis). |
| Residual Powder Test (ASTM D6124-01) | Met "powder-free" claim (no more than 2 mg powder per glove). |
Study Details
Given this is a 510(k) submission for a patient examination glove, the "study" context differs significantly from, for example, a diagnostic AI device. The "studies" here refer to testing performed to ensure the glove meets established safety and performance standards.
The document does not describe a "test set" in the context of machine learning, but rather samples from the manufactured product undergoing quality control and conformance testing.
-
Sample size used for the test set and the data provenance:
- Pinhole (FDA 1000 ml. Water Fill Test): Sampling of AQL 2.5, Inspection Level G-1. (Specific numerical sample size not provided, but these AQL levels imply a defined sample size based on lot size).
- Physical & Dimensions Testing: Sampling of Inspection Level S-2, AQL 4.0. (Specific numerical sample size not provided).
- Biocompatibility (Primary Skin Irritation and Skin Sensitization): No specific sample size mentioned for these tests, typically these involve a smaller, controlled number of subjects or animal models as per standard biocompatibility testing protocols.
- Residual Powder Test: No specific sample size mentioned for this test, but it is conducted at "finished inspection."
- Data Provenance: The tests were conducted internally by Shijiazhuang Tillotson Rubber Products Co., Ltd. as part of their production and quality control process. The country of origin for the data is implicitly China, where the manufacturer is located. The nature of these tests is prospective in the sense that they are performed on newly manufactured batches to ensure ongoing compliance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and submission. The "ground truth" here is defined by objective physical and chemical standards (e.g., specific measurement values, pass/fail criteria for irritation). There are no human "experts" establishing a subjective "ground truth" for interpretations. For the biocompatibility tests, qualified laboratory personnel would interpret the results against established criteria.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, often in image analysis. For glove testing, the results are typically determined by objective measurements and observations against predefined acceptance criteria. For example, a glove either leaks under the water fill test or it doesn't.
-
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 study is not applicable for this device. This type of study is relevant for diagnostic devices (especially AI-powered ones) where human readers (e.g., radiologists) interpret cases and their performance (with or without AI assistance) is evaluated. This device is a medical glove, not a diagnostic tool requiring interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or basis for acceptance) is established by objective technical standards and laboratory test results. This includes:
- Physical measurements (e.g., dimensions, tensile strength based on ASTM D6319-00aE3).
- Performance criteria (e.g., absence of pinholes in the water fill test).
- Chemical analysis (e.g., residual powder content based on ASTM D6124-01).
- Biocompatibility observations (e.g., absence of irritation or sensitization reactions in standardized tests).
- The "ground truth" (or basis for acceptance) is established by objective technical standards and laboratory test results. This includes:
-
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set." The manufacturing process is controlled by established engineering and quality management principles, not by training an algorithm on a data set.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant. The "ground truth" for the overall device's performance as a medical glove is established by its adherence to internationally recognized and FDA-accepted standards like ASTM D6319-00aE3.
§ 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.