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An examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. chemotherapy drugs; Gastric Acid; Xylazine; Fentanyl

Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl

This document is a 510(k) clearance letter for a medical device: "Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl". This type of device is a physical barrier and does not involve AI or imaging analysis, which are the typical contexts for the detailed acceptance criteria and study designs you've requested.

Therefore, many of the specific questions you've asked, such as those related to AI algorithm performance (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable to this device.

However, I can extract the closest analogous information from the provided text about the device's performance against its stated "Indications for Use," which serves as its functional acceptance criteria.

Understanding the Device and its "Acceptance Criteria":

The device is a medical glove. Its primary "acceptance criteria" are related to its ability to prevent permeation by various substances, specifically:

• 60 chemotherapy drugs
• Gastric Acid
• Xylazine
• Fentanyl Citrate

The reported "device performance" is measured by the "Minimum Breakthrough Detection Time (Min.)" when tested according to ASTM D6978-05. The acceptance criterion implied for most tested substances is "no breakthrough detected up to 240 minutes" (i.e., >240 minutes). For two specific drugs, Carmustine and Thiotepa, the breakthrough times are explicitly lower (11 minutes and 39 minutes, respectively), and the label includes a warning that these should not be used with these drugs.

Here's the information parsed from the document, addressing your questions where applicable, and stating "Not Applicable" (N/A) for those that don't fit the context of a physical barrier device or an AI/imaging study:

1. A table of acceptance criteria and the reported device performance

For most substances, the implied acceptance criterion is "no breakthrough detected up to 240 minutes". The reported performance generally meets this, with specific exceptions noted.

Note: The "acceptance criterion" column for Carmustine and Thiotepa is marked N/A because the device performance is clearly below the general threshold of >240 minutes, and instead, the clearance document acknowledges this lower performance and specifies a warning against their use. This means the device is cleared despite not meeting the >240 min criterion for these two specific chemicals, but with a critical warning to users.

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

• Sample Size: Not specified in the provided text. The testing was conducted according to ASTM D6978-05, which would stipulate the required sample sizes for such tests, but the specific number used for this device is not reported.
• Data Provenance: The manufacturer is "GMP Medicare Sdn. Bhd." located in Malaysia. The testing methodology (ASTM D6978-05) is an international standard. Whether the testing was performed in Malaysia or another country is not specified, nor is whether the data is retrospective or prospective, though performance testing for device clearance is typically prospective by nature.

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

• N/A. This device is a physical barrier. "Ground truth" in this context is established by objective laboratory testing (permeation time using analytical methods), not by human expert interpretation (like radiologists for medical images).

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

• N/A. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human annotators/experts, typically in medical imaging or clinical trials. The "test set" here refers to physical samples of gloves subjected to a standardized chemical permeation test. The results are quantitative and objectively measured.

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

• N/A. This is a physical device, not an AI-assisted diagnostic tool. No human "readers" or AI assistance are involved in its primary function or testing for this clearance.

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

• N/A. This is a physical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Objective laboratory measurement/Chemical Permeation Testing: The "ground truth" for this device's performance is the direct measurement of breakthrough time using the standardized ASTM D6978-05 method. This involves analytical detection of the permeating substance on the non-contact side of the glove.

8. The sample size for the training set

• N/A. This is a physical device. There is no "training set" in the context of machine learning. Design and development of the glove material (e.g., nitrile composition) would involve material science and manufacturing processes, but not a machine learning training set.

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

• N/A. As above, no training set for an algorithm is involved.

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

This glove was tested for use with chemotherapy drugs and Fentanyl Citrate as pet ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

This document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim." The core of the submission revolves around demonstrating the glove's resistance to permeation by chemotherapy drugs and Fentanyl.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Nitrile Powder Free Examination Glove's resistance to chemotherapy drugs and Fentanyl permeation are based on the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is the "Minimum breakthrough Detection Time (min)" for each chemical.

The Study that Proves the Device Meets the Criteria:

The study referenced is the testing performed "as per ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard is a recognized methodology for evaluating the integrity of medical gloves when exposed to hazardous chemicals. The table provided directly presents the results of this testing, showing the breakthrough detection times for each specified drug and Fentanyl Citrate.

Remaining Information Not Present in the Document:

The provided document (an FDA 510(k) clearance letter and Indications for Use statement) does not contain the detailed technical information required to answer the following questions:

2. Sample size used for the test set and the data provenance: Not mentioned. The document only presents chemical permeation test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical performance test for a glove, not an AI or diagnostic device requiring expert interpretation of results for "ground truth." The "ground truth" here is the direct measurement of chemical breakthrough time.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus building among human readers for diagnostic interpretation, which is not relevant for a glove permeation test.
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. This is for AI-assisted diagnostic devices, not protective equipment like gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is established by the direct measurement of chemical permeation through the glove material according to the ASTM D6978-05 standard. It is a direct physical measurement.
8. The sample size for the training set: Not applicable. This refers to the training of machine learning models, which is irrelevant for a glove permeation test.
9. How the ground truth for the training set was established: Not applicable. This refers to the training of machine learning models.

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The Biodegradable Nitrile Powder Free Examination Glove (Blue) is a non-sterile disposable device intended for medical purpose that is worn on examinet's hand to prevent contamination between patient and examiner.

Biodegradable Nitrile Powder Free Examination Glove (Blue)

This document is a 510(k) premarket notification letter from the FDA regarding a Biodegradable Nitrile Powder Free Examination Glove (Blue). It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It primarily deals with the regulatory classification, general controls, and other administrative information for getting the device approved for marketing.

Therefore, based on the provided text, I cannot extract the requested information about acceptance criteria and a study proving the device meets those criteria.

This type of information is typically found in the 510(k) summary or detailed test reports, which are not part of this specific letter.

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The Nitrile Powder Free Examination Glove (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

Nitrile Powder Free Examination Glove (Blue)

The provided document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove (Blue)". This type of document is a regulatory approval, not a scientific study report describing acceptance criteria and device performance in the way a clinical trial or algorithm validation study would.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness is not available in this document.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Stating its intended use (Indications for Use).
• Outlining the regulatory requirements the manufacturer must comply with.

Here's what can be extracted from the document based on your request, along with explanations for what cannot be provided:

1. A table of acceptance criteria and the reported device performance

• Not Available in this document. For a medical examination glove, acceptance criteria would typically relate to physical properties (tensile strength, elongation, force at break), barrier integrity (AQL for pinholes), and biocompatibility. Performance data would show how the glove met these specific criteria. This document states substantial equivalence to predicate devices, implying these criteria were met, but does not list them or the specific performance results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available in this document. This document does not detail the testing methodology or sample sizes used to demonstrate compliance with performance standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a physical device (glove) approval, not a diagnostic algorithm or image analysis tool. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this device. Ground truth for a glove would relate to its physical properties and barrier integrity, which are measured objectively.

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

• Not Applicable. As above, this concept doesn't apply to the regulatory approval of an examination glove.

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. This is not a diagnostic device or AI algorithm for image interpretation.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. As explained, the concept of "ground truth" in the diagnostic sense is not relevant for an examination glove. The "truth" would be objective measurements against product standards (e.g., ASTM standards for medical gloves) and biocompatibility testing. The document implies these were met to establish substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. As above, no training set or ground truth in this context.

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A Nitrile powder free examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)

ELEGANT Nitrile Powder Free Examination Gloves

This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.

The provided text pertains to the substantial equivalence determination for "Elegant Blue Violet Nitrile Examination Gloves Ambidextrous Powder-Free" (K120110). It states that the device is a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." (21 CFR 880.6250).

Therefore, none of the requested information (1-9) can be extracted from this document, as it is not relevant to the performance evaluation of an AI-powered device.

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