Search Results

Blue Powder Free Latex Examination Gloves, Non-Sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as a barrier against potentially infectious materials and other contamination.

Latex Patient Examination Gloves, LYY, Powder Free

The provided text describes a 510(k) submission for Blue Powder Free Latex Examination Gloves, Non-Sterile. This submission focuses on medical gloves, which are physical products, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study" in the context of an AI/ML device's performance metrics (like accuracy, sensitivity, specificity, sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) is not applicable here.

The document primarily addresses the glove's compliance with established industry standards and FDA requirements for medical devices, specifically patient examination gloves.

Here's a breakdown of the relevant information provided, adapted to the context of a medical glove:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device "meets ASTM D 3578-01 Standard and FDA's requirement" for quality performance. It also states the device "pass the Biocompatibility Test." Specific numerical performance metrics (like AQL levels for pinholes) are not detailed in this excerpt but would be part of the underlying test reports.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated in the provided text for the quality performance or biocompatibility tests. These would typically be specified in the full test reports referenced by the 510(k) submission.
• Data Provenance: The manufacturing entity is MultiSafe Sdn. Bhd. located in Malaysia. The testing would have been conducted to meet US FDA requirements and international standards (ASTM D 3578, ISO 11193, EN 455). The origin of the raw data/samples tested would be from the manufacturing process in Malaysia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable for a medical glove submission. Ground truth for a physical medical device like a glove is established through adherence to standardized physical, chemical, and biological testing protocols, not expert consensus on interpretations.

4. Adjudication method for the test set:

This concept is not applicable for a medical glove submission. Adjudication is relevant for diagnostic interpretations, not for physical product testing against standardized specifications.

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:

This concept is not applicable as this is a medical glove, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This concept is not applicable as this is a medical glove, not an algorithm.

7. The type of ground truth used:

For a medical glove, the "ground truth" is defined by:

• Standardized Physical and Performance Specifications: E.g., ASTM D 3578-01 for dimensions, tensile strength, elongation, and barrier integrity (absence of pinholes at specified AQL levels).
• Biocompatibility Standards: Absence of irritation or sensitization as determined by standardized in-vivo (animal or human patch) tests.
• Chemical Properties: Compliance with limits for extractable proteins (for latex gloves) if applicable.

8. The sample size for the training set:

This concept is not applicable as this is a medical glove. There is no "training set" in the context of an AI/ML algorithm. The "training" for glove manufacturing would refer to process control and quality system implementation.

9. How the ground truth for the training set was established:

This concept is not applicable as this is a medical glove.

Ask a specific question about this device