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

Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

This document describes the premarket notification (510(k)) for a medical device, specifically "Black Nitrile Powder Free Patient Examination Glove, Non Sterile". It is not an AI/ML medical device submission. Therefore, the questions related to AI/ML specific studies, such as MRMC studies, ground truth establishment by experts, and training/test set sample sizes for AI/ML models, are not applicable.

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (K190942) by meeting established performance standards for patient examination gloves.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance & Comparison Analysis

The document provides a detailed comparison in "Table 1" and further test results in section "7.0 Summary of Non-Clinical Testing".

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Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purpose to provide barrier against potentially infectious materials and other contaminants.

Powder Free Nitrile Examination Gloves is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D 6319 - 10 Standard Specification for Nitrile Examination Gloves for Medical Application¹. They are made from nitrile compound(dispersion of butadiene acrylonitrile copolymer. They are powder free gloves.

The provided text describes powdered-free nitrile examination gloves and their compliance with ASTM standards, rather than an AI/ML powered device. Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document.

However, I can extract the acceptance criteria and performance as described for the gloves.

1. Table of acceptance criteria and the reported device performance

Specific numerical values for tensile strength, elongation, and AQL for pinholes are not explicitly provided in the summary but are stated to meet the ASTM D 6319-10 standard. The document states, "Gloves meet all the current ASTM D 6319-10." and "Non-Clinical laboratory and animal based test data indicate that the powder free product meets all performance and biocompatibility requirements."

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

The document does not explicitly state the sample size used for the test set for all physical and barrier integrity tests. For biocompatibility tests:

• Primary skin irritation: Conducted in rabbits (number of rabbits not specified).
• Delayed dermal contact sensitization: Conducted in guinea pigs (number of guinea pigs not specified).
• Data provenance: The testing was performed in Thailand by W.A. Rubbermate Co., Ltd. The study appears to be non-clinical (laboratory and animal-based).

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

This information is not applicable as the device is a medical glove, not an AI/ML device requiring expert ground truth for classification or diagnosis. Performance is based on standardized physical and biocompatibility testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device and testing.

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

For the glove's performance:

• Physical properties: Measured values (e.g., dimensions, tensile strength, elongation) compared against the specifications in ASTM D 6319-10.
• Freedom from holes: Determined by established inspection methods (e.g., water leak test) and statistical sampling plans (AQL) as defined in ASTM D 6319-10.
• Biocompatibility: Observed biological responses (irritation, sensitization) in animal models compared against established safety criteria.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device. There is no "training set" in the context of physical glove testing.

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

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

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WA Rubbermate Powder-Free Latex Examination Gloves are a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

WA Rubbermate Powder Free Latex Examination Gloves

This document is a letter from the FDA regarding a medical device submission (K021041) for "WA Rubbermate Powder Free Latex Examination Gloves." It is a 510(k) clearance letter, indicating substantial equivalence to a predicate device.

This document does not contain information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device.

The provided text focuses on the regulatory aspects of clearing basic medical gloves, which are subject to general controls and not typically supported by the types of studies and performance metrics detailed in the request. Therefore, I cannot extract the requested information from this document.

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A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Powder Free Latex Patient Examination Gloves

This document, a 510(k) premarket notification from the FDA, deals with the regulatory clearance of "Powder Free Latex Patient Examination Gloves". It focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a study demonstrating the device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the provided text. The document confirms the device's clearance for marketing, but does not detail performance studies.

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