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A Powder Free Nitrile Examination Glove - Blue (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05

Powder Free Nitrile Examination Glove - Blue (Chemotherapy)

The provided document outlines the FDA's substantial equivalence determination for a medical device, specifically "Powder Free Nitrile Examination Glove -- Blue (Chemotherapy)." The primary focus of the document regarding performance is the permeation resistance of these gloves to various chemotherapy drugs.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For chemotherapy gloves, the critical acceptance criterion is the Minimum Breakthrough Detection Time when exposed to specific chemotherapy drugs. The device performance is measured against this criterion. While the document doesn't explicitly state "acceptance criteria" for each drug with a numerical threshold (e.g., "must be > X minutes"), it presents the test results, implying that demonstrating adequate permeation resistance for a certain duration is the goal. For the purpose of this analysis, the reported breakthrough detection times serve as the device's performance against an implicit criterion of maintaining barrier integrity for a reasonable period.

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

• Sample Size: For each chemotherapy drug, the breakthrough detection time is reported with values for three specimens (e.g., "(60.3, 60.5, 60.6)"). Therefore, the sample size for the test set regarding permeation was 3 specimens per drug.
• Data Provenance: The document does not specify the country of origin of the data. It is a submission to the FDA from a Malaysian company (Matang Manufacturing Sdn. Bhd, Melaka, Malaysia). The study appears to be prospective testing specifically conducted for this 510(k) submission, rather than retrospective data analysis.

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

• This information is not provided in the document. The study described is a laboratory test (permeation test) conducted according to a standard (ASTM D 6978-05). It does not involve human interpretation or subjective assessment that would require "experts" to establish a ground truth in the typical sense of clinical studies (e.g., radiologists interpreting images). The "ground truth" here is the objective chemical permeation through the glove material as measured by the testing method.

4. Adjudication Method for the Test Set

• This information is not applicable as the study is a laboratory permeation test, not a study involving human interpretation or subjective assessment that would require an adjudication method among experts. The results for each specimen are reported independently.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, And What Was the Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve multiple readers (e.g., physicians) interpreting cases (e.g., medical images) with and without AI assistance. The described study is a laboratory material performance test for gloves.

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

• This question is not applicable as the device is a physical product (examination glove), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply. The performance reported is that of the physical device under laboratory conditions.

7. The Type of Ground Truth Used

• The "ground truth" used is based on objective laboratory measurements of chemical permeation through the glove material, as defined by ASTM D 6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs). This standard outlines validated methods for determining breakthrough time. It is a direct physical measurement, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• This information is not applicable. The device is a physical product (glove) whose performance is determined through physical testing, not through a machine learning algorithm that requires a training set.

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

• This information is not applicable for the same reason as in point 8.

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A Colored Nitrile Examination Glove - Powder Free (Blue, Black and White) is a disposable device made of Nitrile latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A colors blue, black and white will be added to the nitrile examination glove in the production process to produce the colored gloves.

A Colored Nitrile Examination Glove - Powder Free (Blue, Black and White) is a disposable device made of Nitrile latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A colors blue, black and white will be added to the nitrile examination glove in the production process to produce the colored gloves.

This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML-based medical device. The information requested in your prompt (e.g., sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to the development and validation of such AI/ML devices, which is not applicable to a physical medical device like an examination glove.

Therefore, I cannot provide the requested information based on the provided text.

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A black, powder free and polymer coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A black pigment is added to the latex in the production process to produce the black colored glove.

Black, Powder Free and Polymer Coated Latex Examination Glove with a Protein Claim of Less Than 50 µg/gm Glove

The provided text is a 510(k) premarket notification letter from the FDA regarding a "Black, Powder Free and Polymer Coated Latex Examination Glove with a Protein Claim of Less Than 50 µg/gm Glove."

This document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or software as a medical device (SaMD) product.

Instead, it is a regulatory clearance letter for a physical medical device (medical glove). The "acceptance criteria" and "study" mentioned in your request are typically relevant to the performance evaluation of AI/SaMD, where metrics like sensitivity, specificity, AUC, and clinical effectiveness are assessed.

For this physical device, the "acceptance criteria" would refer to manufacturing standards, biocompatibility, barrier integrity (e.g., freedom from holes), tensile strength, and protein content. The "study" would be testing conducted to demonstrate compliance with these standards, not a clinical trial in the sense of AI performance evaluation.

Therefore, I cannot provide the requested information based on the input text because it does not pertain to an AI/SaMD product.

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

Powder-Free Polychloroprene Patient Examination Glove

This is a 510(k) premarket notification for "Powder-Free Polychloroprene Patient Examination Gloves" and does not contain information about software with acceptance criteria or a study demonstrating device performance.

The provided text is a letter from the FDA confirming substantial equivalence of the gloves to a legally marketed predicate device. It discusses regulatory matters such as registration, listing, good manufacturing practice, and labeling, but does not describe any technical performance criteria or a study with results.

Therefore, I cannot provide the requested information.

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

Matang Powder-Free Latex Patient Examination Gloves with Matang - San Protein Content Labeling Claim of 50 Micrograms or less of total water extractable protein per gram.

The provided text is a Premarket Notification (510(k)) for Powder Free Latex Patient Examination Gloves with Aloe Vera and a Protein Content Labeling Claim of 50 Micrograms or Less of Total Water Extractable Protein Per Gram. This document is a regulatory submission to the FDA, not a study report describing the performance of an AI/ML powered device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the given text.

The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning its safety and effectiveness are considered comparable. The key focus of this submission is on the regulatory classification and the labeling claim regarding protein content.

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

Matang Powder-Free Latex Patient Examination Glove, with Protein Labeling Claim (50 Micrograms or Less)

This document is a 510(k) premarket notification from the FDA, approving the marketing of Matang Powder-Free Latex Patient Examination Gloves with a protein labeling claim. It does not contain the detailed study information typically requested for AI/ML device evaluations. Therefore, I cannot provide the specific information requested in the prompt based on this document.

The document primarily focuses on the regulatory approval process for a medical device (latex gloves) and confirms its substantial equivalence to a legally marketed predicate device. It does not include data from a study on device performance against specific acceptance criteria in the way an AI/ML device submission would.

To answer your prompt, I would need a document that presents the results of a study designed to demonstrate the performance of a device (likely an AI/ML device) against predefined acceptance criteria.

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