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A powder-free patient 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 23.4 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 77.5 minute. Warning statements has been included.
WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA

Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs." This document outlines the FDA's substantial equivalence determination for this medical device.

It does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI-powered diagnostic or similar system.

Instead, the document details the "Indications for Use" for the gloves, which includes their general purpose as examination gloves and their tested performance against specific chemotherapy drugs according to ASTM D6978-05.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, or training set details) from the provided text, as these are not relevant to this type of medical device submission.

The table in the document you provided describes the "Minimum Breakthrough Detection Time (Minutes)" for different chemotherapy drugs when tested with the gloves. This is a performance specification for the gloves regarding chemical permeation, not acceptance criteria for an AI product.

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A powder-free patient 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.

Powder Free Nitrile Examination Gloves, Orange Color

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving that a device meets such criteria.

The document is an FDA 510(k) clearance letter for "Powder-Free Nitrile Examination Gloves, Orange Color" (K141021). This letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new Premarket Approval Application (PMA).

The letter primarily focuses on:

• The trade/device name and regulation information.
• The substantial equivalence determination.
• General controls and regulations applicable to the device.
• Contact information for FDA guidance.
• The "Indications for Use" for the gloves, which defines their intended medical purpose.

There are no details about:

• Specific performance acceptance criteria for the gloves (e.g., tensile strength, puncture resistance, barrier integrity metrics).
• Any study (clinical or non-clinical) that was conducted to demonstrate performance against such criteria.
• Sample sizes for test or training sets.
• Ground truth establishment, experts, or adjudication methods.
• MRMC studies or standalone algorithm performance, as these gloves are a physical medical device, not an AI or software device.

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A powder-free patient 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.

Not Found

This document is an FDA 510(k) clearance letter for Powder-Free Nitrile Examination Gloves with a Mint Scent. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.

Therefore, I cannot provide the requested information based on the provided text. The document is an administrative clearance, not a performance study report.

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A powder-free patient 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05. Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs

The provided text describes the 510(k) premarket notification for "Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs" and includes information about the device's indications for use and performance related to chemotherapy drug permeation. Based on the document, I can extract the acceptance criteria and performance data for chemotherapy drug permeation. However, the document does NOT contain information about a study that would typically include details like sample size for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established in the context of an AI/algorithm-based device. This document is a regulatory submission for a physical medical glove, not an AI/software device.

Therefore, I will only be able to populate the acceptance criteria and device performance table, and explain why other requested information is not applicable to this document.

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For most drugs listed, the implied acceptance criterion is "greater than 240 minutes" of breakthrough detection time, as the device performance meets or exceeds this value for 12 out of 14 drugs. For Carmustine (BCNU) and Thiotepa, the document explicitly notes their "extremely low permeation time" and reports specific values (3.0 and 75.0 minutes, respectively). Therefore, the acceptance criteria for these specific drugs would be defined by the regulatory standard (ASTM D6978-05) and deemed acceptable given the specific performance measured.

Study Details (Information Not Applicable to this Document Type)

The provided document is a 510(k) clearance letter for a physical medical device (examination gloves). It describes the device's intended use and includes testing results for permeation by chemotherapy drugs, conducted in accordance with ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs).

The questions you've asked (regarding sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set ground truth) are typically relevant for studies evaluating Artificial Intelligence (AI) or machine learning algorithms/devices.

Since this document pertains to a physical product (nitrile gloves) and its material properties, the concepts of "test set," "training set," "experts to establish ground truth," "adjudication method," "MRMC study," or "standalone (algorithm only) performance" are not applicable in this context. The "study" referenced is the physical permeation test conducted according to the ASTM standard, not a data-driven AI model evaluation.

Therefore, the requested details are not present in this document because they are not relevant to the type of device and evaluation described.

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A powder-free patient 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.

POWDER-FREE NITRILE GLOVES, BLACK

This is a 510(k) premarket notification for "Powder-Free Nitrile Gloves, Black," which are Class I medical devices (patient examination gloves). The provided document is a substantial equivalence determination letter from the FDA.

Since this document is for a Class I medical device (gloves) and not an AI/ML-powered diagnostic device, many of the requested fields (such as those related to AI model performance, training sets, expert review, MRMC studies, etc.) are not applicable. The traditional "device performance" in this context refers to physical and chemical properties of the gloves, not accuracy in diagnostic tasks.

Here's the closest representation based on the information provided and typical requirements for such devices:

Acceptance Criteria and Study for Powder-Free Nitrile Gloves, Black

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

For patient examination gloves, key performance criteria typically relate to barrier integrity, physical properties, and biocompatibility. While the specific test results are not in this FDA letter, the substantial equivalence determination implies that the device met these criteria, likely by showing equivalence to a predicate device that has demonstrated compliance.

Note: The FDA letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination means that the new device performs at least as well as a legally marketed predicate device. The actual detailed test results demonstrating this equivalence are usually contained within the 510(k) submission itself, not in the FDA's final decision letter.

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

• Sample Size: Not specified in this document. For physical and chemical testing of gloves, sample sizes are typically defined by international standards (e.g., ISO, ASTM) and involve statistical sampling from manufacturing lots.
• Data Provenance: Not specified, but generally refers to data obtained from laboratory testing of the manufactured gloves.

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 product (glove), not a diagnostic device requiring expert interpretation for ground truth. Testing involves laboratory personnel following established protocols.

4. Adjudication method for the test set

• Not Applicable. No human interpretation or adjudication in the context of diagnostic tasks is involved. Testing relies on objective measurements.

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 an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used

• Objective Measurement/Standard Specifications: "Ground truth" for examination gloves typically comes from meeting defined physical, chemical, and biological specifications outlined in recognized standards (e.g., ASTM D6319 for Nitrile Examination Gloves, ISO 10993 for biocompatibility). For example, "freedom from holes" is assessed by a water leak test, and tensile strength by a materials testing machine.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of a manufactured physical product like a glove, as it doesn't involve machine learning or diagnostic image analysis.

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

• Not Applicable.

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A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.

Powdered Patient Nitrile Examination Gloves (White / Blue color)

The provided document is an FDA 510(k) clearance letter for "Powdered Patient Nitrile Examination Gloves (White/Blue Color)." This document does not contain information about acceptance criteria or a study proving that a device (in the sense of a software algorithm or diagnostic tool) meets acceptance criteria.

The letter pertains to the substantial equivalence of a physical medical device (gloves), and therefore the questions about algorithm performance, ground truth, expert review, sample sizes for training/test sets, and MRMC studies are not applicable.

The document states:

• Device Name: Powdered Patient Nitrile Examination Gloves (White/Blue Color)
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Product Code: LZA
• Indications for Use: A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.

This is a regulatory clearance for a physical product, not a software or AI-driven diagnostic device. Therefore, the requested information (table of performance, sample sizes for test/training, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, etc.) is not present in this type of document.

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

Powder - Free Nitrile White and Blue Examination Gloves

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for "Powder-Free Nitrile White and Blue Examination Glove" and an "Indication for Use" statement from the manufacturer.

This document describes the regulatory clearance of a medical device (examination gloves) based on substantial equivalence to a legally marketed predicate device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML powered device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

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