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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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