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This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below

Do not use with Carmustine and Thiotepa.

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes.

The Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D6319-10. It is an ambidextrous medical glove, which is a disposable device, provided in x-small, medium, large and xlarge sizes. In addition, these gloves were tested for use with chemotherapy drugs per ASTM D6978-05 "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," and Modified-Draize-95 Test, per FDA guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products," 1999.

The provided text describes the acceptance criteria and performance of a medical device, specifically a "Powder-free Nitrile Patient Examination Glove." This document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device.

It's important to note that this document does not describe an AI/ML medical device. The "device" in question is a physical glove, and the "tests" are for its physical properties and chemical resistance, not for an algorithm's performance on a dataset. Therefore, many of the requested fields related to AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and how the glove's performance was proven based on the provided text.

Acceptance Criteria and Device Performance (for a physical medical glove)

The document primarily focuses on demonstrating that the subject device (the green nitrile glove) is substantially equivalent to a predicate device (blue or white nitrile gloves) by meeting established standards for patient examination gloves and resistance to chemotherapy drugs.

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug Permeation Specifics (from "Indications for Use" and "Technological Characteristics" tables):

Important Note: The document explicitly states "Do not use with Carmustine and Thiotepa" due to their extremely low permeation times, even though the subject device still improved upon Carmustine's breakthrough time compared to the predicate.

Regarding the AI/ML-specific questions (which are not applicable to this physical glove device):

2. Sample sizes used for the test set and the data provenance: Not applicable. Testing was on physical glove samples from various production lots, not on a dataset in the AI/ML context. Data provenance is implied to be from the manufacturer's testing of their product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (e.g., hole in glove, chemical permeation) is established through standardized laboratory tests, not human expert consensus. "Experts" would be laboratory technicians or chemists.
4. Adjudication method for the test set: Not applicable. Laboratory tests follow predefined protocols; no human adjudication is mentioned or implied for test results.
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 a physical device, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used: For physical and chemical tests, the ground truth is objective measurement against established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. For biocompatibility, it's the biological response in standardized in-vitro or in-vivo (human repeat insult patch testing) models.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LA, and meets all requirement of ASTM Standard D6319-10.

Device Acceptance Criteria and Performance Study Analysis:

1. Table of Acceptance Criteria and Reported Device Performance:

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LZA; and meets all requirement of ASTM Standard D6319-10.

The document provided describes the acceptance criteria and study proving the device meets those criteria for the "Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue Color" by Xinwei (Shandong) Plastic and Rubber Products Co., Ltd.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "samplings of AOL 2.5, Inspection Level I" for the FDA 1000 ml. Water Fill Test and "Inspection Level S-2, AOL 2.5" for Physical and Dimension Testing. These are standard acceptance quality limits (AQLs) and inspection levels found in sampling plans (e.g., ISO 2859-1 or MIL-STD-105E). While the specific number of gloves sampled is not explicitly stated, these levels correspond to a defined sample size based on the lot size.

The data provenance is retrospective, as the tests were performed on finished products to demonstrate compliance with existing standards. The country of origin for the device manufacturer is China (Xinwei (Shandong) Plastic and Rubber Products Co., Ltd.), and the predicate device manufacturer is also from Tangshan Zhonghong Pulin Group Co., Ltd. (China, implied by other similar K-summaries for this manufacturer).

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

Not applicable to this type of device. The ground truth for this device is based on objective measurements against established engineering and biocompatibility standards, not expert medical opinion or diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This evaluation does not involve subjective interpretation requiring adjudication among experts. The tests are objective measurements.

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 or interpretive devices where human readers are involved in assessing cases, often with and without AI assistance. Examination gloves are physical barriers, not diagnostic tools.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm or software requiring standalone performance testing. It is a physical product.

7. The Type of Ground Truth Used:

The ground truth used is based on established engineering standards and biocompatibility testing guidelines. Specifically:

• ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) for dimensions and physical properties.
• ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves) or FDA 1000 ml. Water Fill Test for pinholes.
• ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves) for residual powder.
• ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) for primary skin irritation and dermal sensitization.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this device.

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A 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 pariesoo and examiner. This device is not intended to be used as a chemical barrier.

Powder-free Nitrile Patient Examination Glove, White (non-colored) and Blue Colored, Tested for use with Chemotherapy Drugs

This document is a 510(k) premarket notification letter from the FDA regarding a Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored, Tested for use with Chemotherapy Drugs.

The letter states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details (like sample sizes, ground truth establishment, or expert qualifications).

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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A 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 Patient Examination Gove, White (non-colored) and Blue Colored

I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Nitrile Patient Examination Glove." It discusses the regulatory classification and marketing authorization of the device.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These types of details are typically found in the 510(k) summary or detailed reports, which are not included in the provided text.

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A 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 Patient Examination Glove, White (non-colored), Blue and Green Colored

The provided text is a 510(k) premarket notification letter from the FDA regarding a Powder-Free Nitrile Patient Examination Glove. This document confirms that the device is substantially equivalent to a predicate device already on the market and does not require an approval for a premarket approval application (PMA).

The document does not detail any studies, acceptance criteria, or performance metrics for the device. It is a regulatory letter of approval based on the substantial equivalence principle, rather than a report on device performance testing. As such, I cannot provide the requested information from the given text.

The information I can extract directly from the provided text is:

• Device Name: Powder-Free Nitrile Patient Examination Glove, White (non-colored), Blue and Green Colored
• Intended Use: A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Regulatory Class: I
• Product Code: LZA
• Regulation Number: 880.6250 (Patient Examination Gloves)

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A 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 Patient Examination Glove, Violet Color.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) premarket notification letter for a patient examination glove, detailing its classification, regulatory requirements, and indications for use. It does not include any performance data, study designs, or details about ground truth establishment.

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Ask a specific question about this device

A 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 Patient Examination Glove, White (Non-Colored)

This document is a 510(k) clearance letter from the FDA for a medical device: "Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)".

The FDA clearance process for Class I devices like examination gloves primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves performance testing against recognized standards rather than a clinical study with human readers or complex statistical analyses of diagnostic accuracy.

Therefore, many of the requested details, such as multi-reader multi-case studies, expert adjudication methods, and standalone algorithm performance, are not applicable to this type of device clearance.

Here's an attempt to answer the questions based on the information provided and the general understanding of 510(k) for examination gloves:

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

The document itself does not contain a table of acceptance criteria or reported device performance. For examination gloves, acceptance criteria are typically based on recognized international standards such as ASTM D6319 (for nitrile examination gloves) or ISO 11193 (for single-use medical examination gloves), which define requirements for physical properties like tensile strength, elongation, and barrier integrity (e.g., freedom from holes).

The FDA's review letter states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This implies that the device met the performance criteria equivalent to the predicate device, which would mean it complied with the relevant standards for examination gloves.

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

The document does not specify the sample size or data provenance for any testing. For examination gloves, this would typically involve laboratory testing of a statistically relevant sample size from manufactured lots to demonstrate compliance with physical and barrier properties. This testing is usually prospective, conducted by the manufacturer, and the country of origin would be Malaysia (where the manufacturer is located).

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. For examination gloves, the "ground truth" is established by direct physical and chemical measurements against defined standards, not by expert interpretation of images or clinical data.

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

Not applicable. There is no adjudication method for the physical and performance testing of examination gloves.

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 device is an examination glove, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

Not applicable. This device is an examination glove, not an algorithm.

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

For examination gloves, the "ground truth" for performance would be based on objective measurements of physical properties (e.g., tensile strength, elongation at break) and barrier integrity (e.g., water leak test) as defined by recognized consensus standards (e.g., ASTM, ISO).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of device clearance for examination gloves. The manufacturing process is controlled, and product testing ensures consistency.

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

Not applicable. See point 8.

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A 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 Patient Examination Glove (Blue /Green)

This looks like a 510(k) clearance letter for medical gloves, not a report about a diagnostic device or AI algorithm. Therefore, the questions regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not applicable to the provided document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than meeting specific performance criteria through a detailed study as would be expected for a novel diagnostic device or AI.

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