Search Results

This Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate, with Protein Labeling claims (50 Micrograms or less) 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.

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Gloves for Medical Application.

Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves

This report summarizes the acceptance criteria and device performance for the "POWDER-FREE LATEX EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)" developed by SGMP Company Limited. The information is extracted from the provided 510(k) summary (K07/060).

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the ASTM D3578-01aE2 and ASTM D3578-00aE2 standards for latex examination gloves, as well as FDA requirements for powder-free gloves and protein labeling.

2. Sample Size Used for the Test Set and Data Provenance

• Dimension: Specific sample sizes are not explicitly stated, but the "SGMP" column provides data ranges or single values, implying testing was done.
• Physical Properties: For "Lot# 6171," the test results are reported for X-Small, Small, Medium, and Large sizes, both before and after aging. No specific number of gloves per size within Lot# 6171 is provided for these physical properties.
• Water Tight Test: 125 pieces of each glove size (X-Small, Small, Medium, Large) from "Batch # 6171" were tested, both un-aged and aged, for a total of 8 batches of 125 gloves (1000 individual gloves).
• Residual Powder Content & Presence of Cornstarch: The results are reported as a range and mean for residual powder, and a single "Negative" for cornstarch, indicating testing was performed, but specific sample size is not mentioned.
• Residual Protein Level: No specific sample size is given for this test.

Data Provenance: The data appears to be retrospective and gathered from internal testing conducted by SGMP Company Limited (Thailand), the manufacturer of the device. The data is presented as direct test results from their products, measured against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given text. For medical devices like examination gloves, the "ground truth" is typically defined by adherence to established industry standards (like ASTM) and regulatory requirements (like FDA's AQL for pinholes). These standards are developed through a consensus process involving experts in the field, but individual expert adjudication of specific test results for this 510(k) submission is not described. The manufacturer reports their own test results against these predefined standards.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies involving human interpretation or expert evaluation, often in medical imaging or diagnostic contexts, where there might be disagreement among initial assessors.

For this device (examination gloves), the "adjudication" is essentially the direct measurement and comparison of physical and chemical properties against objective, predefined industry and regulatory standards. There is no indication of human expert adjudication of individual test outcomes beyond the standard quality control and laboratory procedures to ensure accurate measurements. The reported values are direct measurements (e.g., tensile strength, length, number of leaks) that are then compared to the numerical thresholds set by the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic devices where human readers interpret medical data (e.g., radiologists interpreting images) and the AI's effect on their performance is evaluated. This submission is for medical examination gloves, which do not involve human interpretation of data in the same way, nor the use of AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone (algorithm-only) study was not done, as this product is not an AI/algorithm-driven device. The performance described is purely for the physical product itself, based on direct physical and chemical testing.

7. The Type of Ground Truth Used

The ground truth used for this study is primarily established industry standards and regulatory requirements. Specifically:

• ASTM D3578-01aE2 and ASTM D3578-00aE2 Standard Specifications for Latex Examination Gloves for Medical Application: These standards define the acceptable ranges and minimums for dimensions, tensile strength, ultimate elongation, and AQL for pinholes.
• FDA requirements: Such as the 1,000 ml water leak test for pinholes and the maximum limit for residual powder content (2 mg/glove).
• Other ASTM standards: ASTM D 6124-00 for residual powder content and ASTM D 5712-99 for residual protein level.

These standards serve as the objective benchmarks against which the device's performance is measured.

8. The Sample Size for the Training Set

This concept is not applicable. The device is a physical product (examination gloves), not an AI/machine learning model that requires a "training set." The information provided describes the testing of the manufactured product directly against established performance criteria.

9. How the Ground Truth for the Training Set Was Established

This concept is not applicable. As there is no AI/machine learning model, there is no "training set" or ground truth for such a set to be established. The ground truth for evaluating the physical product is defined by the existing ASTM and FDA standards.

Ask a specific question about this device