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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.

This document describes the performance data for KOH2101, Powder Free Nitrile Examination Gloves, manufactured by SEAL Polymer Industries Berhad. The device is a Class 1 Nitrile Patient Examination Glove intended for medical purposes to prevent contamination between patients and examiners. The performance data is based on ASTM D6319-00a53 and FDA 1000 ml watertight test.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The average numbers for physical properties are obtained from Attachment C, which is not provided in this document.

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

The document does not explicitly state the specific sample sizes used for each test criterion. However, all tests are performed according to ASTM D6319-00aE3 and FDA 1000 ml watertight test standards, which define the testing methodologies and potentially the sample sizes. The data provenance is Malaysia, as the submitter, SEAL POLYMER INDUSTRIES BERHAD, is located in Perak, Malaysia. The study appears to be a prospective examination of the manufactured gloves to ensure they meet the defined standards.

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

Not applicable. The ground truth for glove performance is established by standardized testing protocols (ASTM D6319-00aE3 and FDA 1000 ml watertight test), not by expert consensus in the typical sense of diagnostic imaging or clinical decisions.

4. Adjudication Method for the Test Set:

Not applicable. The performance is determined by objective measurements against predefined criteria in the ASTM and FDA standards. There is no mention of an adjudication process by multiple experts for disputes in results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, not for examination gloves whose performance is assessed through physical and chemical tests.

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

Not applicable. This is a medical device (examination glove), not an algorithm or AI system. Its performance is inherent to the product's physical and chemical properties as measured by standardized tests.

7. The Type of Ground Truth Used:

The ground truth used is based on established industry standards and regulatory requirements. Specifically, it relies on:

• ASTM D6319-00aE3 Standard: This standard specifies requirements for medical gloves for single use.
• FDA 1000 ml watertight test: This is a regulatory requirement for acceptable barrier integrity.
• Biocompatibility Tests: Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test, which determine the biological safety of the gloves.
• FDA minimum powder residual content: A regulatory requirement for powder-free gloves.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of physical medical device testing for examination gloves. The manufacturing process is controlled, and the product is tested against predefined specifications.

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

Not applicable, as there is no training set for this type of device and study.

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