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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. The device is for over-the-counter use.

The proposed Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, Not made with natural rubber latex and is made of nitrile (Butyronitrile latex) . It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile. The device is provided in 4 sizes, from small to extra-large.

The provided text is a 510(k) Summary for Nitrile Examination Gloves (K212929). It does not describe an AI/ML-based medical device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI/ML device meets those criteria.

The document discusses the following for the Nitrile Examination Gloves:

• Acceptance Criteria and Reported Device Performance (Table I and II): These tables detail physical properties (dimensions, tensile strength, elongation), freedom from holes, residual powder, and biocompatibility tests (irritation, sensitization, systemic toxicity, cytotoxicity). The "Reported Device Performance" is the "Proposed Device Nitrile Examination Gloves" column in Table I and the "Results" column in Table II, showing that the product meets or exceeds the specified acceptance criteria for each test.
• Study Proving Device Meets Acceptance Criteria: The study proving the device meets the acceptance criteria consists of adherence to established ASTM and ISO standards for examination gloves. These are non-clinical (laboratory) tests.
• Sample Size: For the physical dimensions and properties, the sample sizes are not explicitly stated, but the ASTM standards followed would specify these. For "Watertightness Test for Detection of Holes," the result is "0/200/Pass," implying a sample size of 200 gloves tested.
• Data Provenance: The data provenance is from laboratory testing performed on the "Proposed Device Nitrile Examination Gloves." The country of origin of the data is not specified, but the manufacturer is WATCHTOWER PPE SUPPLIES, INC. located in Hicksville, New York, USA. The tests are non-clinical, so the concepts of retrospective/prospective clinical data do not apply.
• Experts/Ground Truth/Adjudication/MRMC/Standalone: These concepts are relevant to AI/ML device studies where human expert input is used to establish ground truth or evaluate AI performance. They are not applicable to the non-clinical, physical, and biological testing of examination gloves.
• Training Set: There is no training set mentioned because this is not an AI/ML device.

In summary, the provided document describes the regulatory clearance for a physical medical device (nitrile examination gloves) based on non-clinical performance and biocompatibility testing against established standards, not an AI/ML device.

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