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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 POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Powder Free Nitrile Patient Examination Gloves are made of Nitrile rubber; available in four different colors (White, Cobalt Blue, Black, and Ice Blue) and five different sizes (XS-XL). The subject device is provided non-sterile and is a barrier.

The provided document is a 510(k) summary for POWDER FREE Nitrile GLOVES. It describes the device's characteristics and compares it to a predicate device to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

Device Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue)
Predicate Device Name: Powder free Patient Examination Gloves, Blue Color (K131440)

Note: "SE" in the "Comparison Result" column indicates "Substantially Equivalent" based on the provided document. "Analysis 1, 2, 3" refer to the specific analyses provided in the document to justify substantial equivalence despite minor differences.

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

The document describes non-clinical bench tests performed to verify design specifications and compliance with standards. It does not provide specific sample sizes for these tests.

• Sample Size for Test Set: Not explicitly stated for each test (e.g., number of gloves tested for tensile strength or holes). The document refers to compliance with standards like ASTM D6319 and ISO 2859-1 which define sampling procedures (e.g., AQL for lot-by-lot inspection), but the specific number of units tested is not given.
• Data Provenance: The tests were conducted internally by the manufacturer, HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD, or a contracted lab for biocompatibility. The country of origin for the data is implicitly China, where the manufacturer is located. The nature of the tests (bench tests, physical property measurements, chemical analysis) is retrospective from the perspective of their inclusion in the 510(k) submission, confirming existing product specifications.

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

Not applicable for this type of device and study. The "ground truth" for medical gloves is established by compliance with recognized consensus standards (e.g., ASTM, ISO) which define acceptable physical properties, safety, and performance characteristics. These standards are developed through expert consensus within respective fields, but no individual experts are cited as establishing ground truth for this specific submission's test set.

4. Adjudication Method for the Test Set

Not applicable. The objective performance metrics are measured against quantitative specifications defined by the relevant ASTM and ISO standards. There is no subjective assessment or adjudication required.

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 used for diagnostic devices that involve human interpretation of images or other data to assess the impact of an AI algorithm on human reader performance. Nitrile examination gloves do not involve human interpretation in a diagnostic context.

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

Yes, the studies presented are effectively "standalone" in the context of the device's function. The performance metrics (tensile strength, elongation, freedom from holes, powder content, biocompatibility, dimensions) are inherent properties of the glove itself, measured directly through physical and chemical tests, independent of human interaction during their use. There is no AI algorithm in this device.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these medical gloves is based on:

• Consensus Standards: Specifically, ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D5151-06 (Reapproved 2011) (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D6124-06 (Reaffirmation 2011) (Standard Test Method for Residual Powder on Medical Gloves), and ISO 10993-10: 2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization).
• Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical glove, not an AI/ML algorithm that requires a training set. The term "training set" is relevant for AI models, not for traditional medical devices like examination gloves.

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 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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