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The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is in black color, non-sterile and can be available in six specifications: XS, S, M, L, XL, XXL. It meets all of the requirements of ASTM standard D6319-19.

The provided document is a 510(k) Premarket Notification from the FDA for "Disposable Medical Examination Nitrile Gloves." It details the device's characteristics, intended use, and comparison to a predicate device, along with non-clinical testing results.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Disposable Nitrile Gloves are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue or black color, powder free, nitrile ambidextrous gloves. The gloves are offered in large (L) size, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.

The provided text describes the 510(k) premarket notification for Disposable Nitrile Gloves (ABC-DG01). It outlines the device's characteristics, its intended use, and a comparison to a predicate device (K171422). The submission focuses on demonstrating substantial equivalence through non-clinical testing.

Here's an analysis of the provided information to address your request:

Based on the provided document, the "device" in question is Disposable Nitrile Gloves (ABC-DG01). This is a Class I medical device, meaning it is considered low risk and subject to general controls. The acceptance criteria and "study" described are for physical and chemical performance, not for a diagnostic algorithm or AI.

Therefore, many of the questions regarding AI-specific studies (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.

The "study" refers to non-clinical performance testing conducted to demonstrate that the Disposable Nitrile Gloves meet established standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The relevant information is found in "Table 4. Performance Comparison" and "Summary of Non-Clinical Testing" (specifically the table under section G).

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The Disposable nitrile gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The Disposable nitrile gloves are powder free nitrile examination gloves. The Disposable nitrile gloves will be provided in blue. It can be available in four specifications: S,M,L and XL. And it is non-sterile.

This document is a 510(k) submission for disposable nitrile gloves. It is primarily concerned with establishing substantial equivalence to a predicate device, not with a clinical study of AI performance. Therefore, many of the requested elements regarding AI model acceptance criteria and study design are not applicable to this document.

However, I can extract information related to the device's performance acceptance criteria and how they were proven in a non-clinical setting.

Here's the breakdown based on the provided document:

Device: Disposable nitrile gloves (K223280)
Purpose of the document: To demonstrate substantial equivalence to a legally marketed predicate device (K212924) and obtain FDA clearance for marketing.

Acceptance Criteria and Reported Device Performance

The device performance is evaluated against established ASTM and ISO standards for examination gloves.

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

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The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. This device is a disposable product, provided non-sterile.

The Powder Free Nitrile Gloves are non-sterile disposable patient examination gloves. The gloves are blue and powder free. The Powder Free Nitrile Gloves come in four sizes: Small, Medium, Large, X Large. The Powder Free Nitrile Gloves act as a barrier to prevent contamination between patient and examiner. The device meets all requirements of ASTM D6319-19.

The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Gloves. This document describes the substantial equivalence of the subject device to a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/software as a medical device (SaMD) or any comparative effectiveness study with human readers improving with AI assistance.

Therefore, many of the requested points related to AI/SaMD performance, ground truth establishment for AI training/testing, MRMC studies, expert adjudication, and effect sizes are not applicable within the context of this document.

This document focuses on proving the physical and chemical properties of a medical glove meet established ASTM and ISO standards for safety and effectiveness, similar to a legally marketed predicate device.

Here's the information that can be extracted from the provided text:

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

The document provides a comprehensive table outlining the acceptance criteria (standards) and the reported performance of the Powder Free Nitrile Gloves.

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The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.

The Glovanil™ Blue Nittile Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.

Glovatex™ White Latex Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are in white color, non-sterile and powder free.

Glovanil™ Blue Nitrile Gloves are manufactured to meet all the current specifications listed under the ASTM Specification ASTM D6319 - 19 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile compound. These gloves are in Blue color, non-sterile and powder free.

This document is a 510(k) premarket notification for medical gloves, and as such, it does not describe an AI/ML device. Therefore, the questions related to AI/ML device performance (such as effect size, standalone performance, ground truth establishment, training set size, and expert qualifications for ground truth) are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through physical and biocompatibility testing.

Here's the information extracted concerning the acceptance criteria and device performance for the two glove products described:

1. Table of Acceptance Criteria and Reported Device Performance

Glovatex™ White Latex Gloves (Predicate: K192329)

Glovanil™ Blue Nitrile Gloves (Predicate: K200326)

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

The document does not specify the exact sample sizes used for each physical and chemical test. It only provides the performance results (e.g., average length, tensile strenth values) across different glove sizes. The provenance of the data is from laboratory testing performed on the "subject device" (the Glovatex White Latex Gloves and Glovanil Blue Nitrile Gloves) to demonstrate compliance with referenced ASTM and ISO standards. This is prospective testing for the purpose of the 510(k) submission.

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

Not applicable, as this is not an AI/ML device study. Performance is measured against established industry standards (ASTM, ISO).

4. Adjudication method for the test set

Not applicable, as this is not an AI/ML device study requiring expert adjudication of outputs. Compliance is determined by whether the test results meet the numerical and qualitative specifications of the referenced standards.

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

The "ground truth" for the device performance is the set of specifications and requirements outlined in the referenced consensus standards:

• ASTM D3578-19 (Standard Specification for Rubber Examination Gloves)
• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D6124-06/2017 (Standard Test Method for Residual Powder on Medical Gloves)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ISO 10993-5:2009(E) (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
• ISO 10993-10:2010(E) (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
• ISO 10993-11:2017(E) (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
• USP 41 (Pyrogen Test)

8. The sample size for the training set

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

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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The Disposable Medical Nitrile gloves intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are composed of Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and blue colorant Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and a rolled rim at the cuff edge.

The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The document provided is a 510(k) summary for Disposable Medical Nitrile gloves (K213851) and thus describes non-clinical performance testing rather than a study for an AI-powered device. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted from the provided text, focused on the acceptance criteria and the tests performed for the Disposable Medical Nitrile gloves:

1. Table of Acceptance Criteria and Reported Device Performance

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A disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim atthe cuff edge.

The examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

This document is a 510(k) Pre-Market Notification for "Nitrile Gloves (Model: NE01)". It does not describe an AI medical device. Therefore, many of the requested fields are not applicable.

Here's the information extracted from the provided text, focusing on the device's acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

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The Examination gloves-Type C (Nitrile gloves) 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.

The proposed device is one kind of patient examination glove made from nitrile rubber compounds. The typical characters of these examination gloves are blue color, single-layer, powder-free, non-sterilized, single-use, variable size (see table 2.). These examination gloves can be worn on the examiner's hands or fingers during a medical examination. In addition, it is for over-the-counter use and also for adult use only.

This document summarizes the acceptance criteria and performance data for Examination gloves - Type C (Nitrile gloves), as presented in the provided FDA 510(k) Premarket Notification.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test within the "Non-Clinical Testing" section. However, the tests are conducted in conformance with recognized international and national standards (ASTM, ISO), which typically specify appropriate sample sizes and methodologies.

The provenance of the data is not explicitly stated in terms of country of origin, but it is derived from non-clinical laboratory testing performed by the manufacturer, Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., located in Nanchang City, Jiangxi Province, China. The data is retrospective, as it represents results from tests already performed on the finished device to demonstrate compliance.

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

This information is not applicable. The device in question is a physical medical device (examination gloves), and the "ground truth" for its performance is established through objective, standardized laboratory tests (e.g., water leakage for pinholes, mechanical strength tests, chemical analysis for residual powder, and biological safety assessments). These are not typically assessed by human experts establishing a "ground truth" in the way, for example, a radiologist would for an AI image analysis system.

4. Adjudication Method for the Test Set

This information is not applicable. The tests performed are objective, quantitative measurements or qualitative observations (e.g., "no irritation") based on standardized protocols rather than subjective interpretations requiring adjudication among multiple human reviewers.

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 typically conducted for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This document pertains to non-AI-powered examination gloves.

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

This information is not applicable. The device is a physical product (examination gloves), not an algorithm or software requiring a standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth for the performance of the examination gloves is established through:

• Standardized Test Methods: Adherence to established industry standards like ASTM (e.g., D5151-19 for holes, D6319-19 for physical properties, D6124-06 for residual powder) and ISO (e.g., 10993-10 for irritation/sensitization, 10993-11 for systemic toxicity).
• Objective Measurements: Quantitative measurements (e.g., length, width, thickness, tensile strength, elongation, residual powder amount) with defined acceptable ranges.
• Biological Assessments: Standardized biological evaluations to determine irritation, sensitization, and systemic toxicity, with "no irritation," "no sensitization," and "no acute systemic toxicity" as the ground truth for biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. This device is an examination glove, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for this device.

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The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The provided text is a 510(k) Premarket Notification from the FDA for "Disposable Nitrile Gloves." This document primarily focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving that it meets acceptance criteria for an AI/algorithm-based diagnostic device through a study with human readers.

Therefore, the information requested in the prompt, such as acceptance criteria for AI algorithms, sample sizes for AI test sets, expert adjudication methods, MRMC studies, standalone AI performance, ground truth establishment for training sets, and the number and qualifications of experts for ground truth, is not applicable to this document.

The document describes performance testing for a physical medical device (gloves) against established standards for physical properties and biocompatibility.

Here's an analysis based on the information available in the document, framed to address the prompt's structure where possible, but highlighting the inapplicability of AI-specific criteria.

Analysis of Acceptance Criteria and Device Performance (for Disposable Nitrile Gloves)

The document, K211781, describes the submission for Disposable Nitrile Gloves. The "acceptance criteria" in this context refer to the performance specifications and safety standards for the physical product, not for an AI/algorithm. The study presented is a series of non-clinical bench tests and biocompatibility assessments demonstrating the gloves meet these standards and are substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are derived from recognized standards (ASTM and ISO). The reported device performance shows the proposed device meets or exceeds these criteria.

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The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The provided document describes the non-clinical performance testing for "Disposable Nitrile Gloves" (K212009) to demonstrate substantial equivalence to a predicate device (K171422).

Here's the breakdown of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|-----|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| 1 | ISO 10993-10:2010 (Skin Sensitization Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin sensitization. | Grades less than 1, otherwise sensitization. | All grades are 0. All animals survived and no abnormal signs were observed. |
| 2 | ISO 10993-10:2010 (Skin Irritation Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin irritation. | Primary irritation index of 0-0.4 for negligence. | Primary irritation index is 0. The response of the proposed device was categorized as negligible. |
| 3 | ISO 10993-5:2009 (Cytotoxicity) | Assesses the in vitro cytotoxicity of medical devices. | Viability percentage (Viab.%) of the 100% extract of the test article is the final result. If viability is reduced to

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