Search Results

The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.

The Glovanil™ Blue Nittile Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.

Glovatex™ White Latex Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are in white color, non-sterile and powder free.

Glovanil™ Blue Nitrile Gloves are manufactured to meet all the current specifications listed under the ASTM Specification ASTM D6319 - 19 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile compound. These gloves are in Blue color, non-sterile and powder free.

This document is a 510(k) premarket notification for medical gloves, and as such, it does not describe an AI/ML device. Therefore, the questions related to AI/ML device performance (such as effect size, standalone performance, ground truth establishment, training set size, and expert qualifications for ground truth) are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through physical and biocompatibility testing.

Here's the information extracted concerning the acceptance criteria and device performance for the two glove products described:

1. Table of Acceptance Criteria and Reported Device Performance

Glovatex™ White Latex Gloves (Predicate: K192329)

Glovanil™ Blue Nitrile Gloves (Predicate: K200326)

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

The document does not specify the exact sample sizes used for each physical and chemical test. It only provides the performance results (e.g., average length, tensile strenth values) across different glove sizes. The provenance of the data is from laboratory testing performed on the "subject device" (the Glovatex White Latex Gloves and Glovanil Blue Nitrile Gloves) to demonstrate compliance with referenced ASTM and ISO standards. This is prospective testing for the purpose of the 510(k) submission.

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

Not applicable, as this is not an AI/ML device study. Performance is measured against established industry standards (ASTM, ISO).

4. Adjudication method for the test set

Not applicable, as this is not an AI/ML device study requiring expert adjudication of outputs. Compliance is determined by whether the test results meet the numerical and qualitative specifications of the referenced 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

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for the device performance is the set of specifications and requirements outlined in the referenced consensus standards:

• ASTM D3578-19 (Standard Specification for Rubber Examination Gloves)
• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D6124-06/2017 (Standard Test Method for Residual Powder on Medical Gloves)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ISO 10993-5:2009(E) (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
• ISO 10993-10:2010(E) (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
• ISO 10993-11:2017(E) (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
• USP 41 (Pyrogen Test)

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Ask a specific question about this device