Search Results

A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.

The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

The provided document outlines the acceptance criteria and performance of a device, but it is not a study in the typical sense of a clinical trial or comparative effectiveness research. Instead, it is a 510(k) Premarket Notification Summary for a medical device (Powdered Latex Examination Gloves, Non Sterile), which aims to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and reported device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states:

• "The samples are from the final product." (for non-clinical performance data)
• "The sample items used during the Primary Skin Irritation Test and the Dermal Sensitization Test is from the final product." (for clinical performance data, which in this context refers to biocompatibility testing).

Sample Size: The exact sample size used for each specific test (e.g., how many gloves were tested for pinholes, how many rabbits for biocompatibility) is not specified in the provided summary.
Data Provenance: The device manufacturer is PT. MAHAKARYA INTI BUANA, located in SUMUT – INDONESIA. This suggests the testing was either conducted in Indonesia or by a laboratory contracted by the Indonesian manufacturer. The data appears to be prospective in the sense that the tests were performed specifically for this 510(k) submission on samples of the final product.

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

Not applicable/Not described. This document is for a physical medical device (gloves), not an AI diagnostic or image analysis system. The "ground truth" here is objective physical and chemical measurements (e.g., dimensions, protein content, water leak) and results of standardized biological tests (e.g., skin irritation in rabbits), not expert interpretation of medical images or patient outcomes. Therefore, there's no mention of experts establishing ground truth in the way it would be for an AI study.

4. Adjudication Method for the Test Set

Not applicable. As mentioned above, this is about objective measurements against predefined standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. No MRMC study was performed or is relevant for this type of device (examination gloves). This type of study focuses on improving human reader performance with AI assistance, which is not the purpose of this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a passive physical barrier, not an algorithm or software. Therefore, the concept of standalone algorithm performance does not apply.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Objective Measurements: Directly measurable physical and chemical properties of the gloves (e.g., dimension, weight of powder, protein concentration).
• Standardized Test Results: Outcomes of well-established test methods described by ASTM standards and FDA regulations (e.g., water leak test for pinholes, specific tests for biocompatibility like Primary Skin Irritation in Rabbits and Dermal Sensitization).

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device and does not involve AI or machine learning models that require a "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device