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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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