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Powder-Free Nitrile Examination Glove Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Non-Sterile, is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. The gloves are lined with cotton flock, ambidextrous with beaded cuff, black colored, single use disposable devices that comes is six sizes (XS, S, M, L, and XL) supplied in non-sterile state. The gloves are made of synthetic rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical and performance characteristics meet all requirements of ASTM D6319-10. Powder was not used for this glove's manufacturing process.

This document describes a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves Flock-Lined, Black Color." The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the testing of the new device for dimensions, physical properties, freedom from pinholes, or powder residual. It only states "Meets" for these criteria.

For biocompatibility, the tests were conducted according to ISO 10993-10:2010. The specific number of rabbits used for primary skin irritation or the number of subjects for dermal sensitization tests is not mentioned.

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in relation to the specific tests performed for the new device. However, the manufacturer is stated as "ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD" in ZHANGJIAGANG CITY, CHINA. This suggests the testing data likely originated from China.

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

This information is not applicable and not provided in the document. The device in question is a medical glove, and its performance is evaluated against established ASTM and ISO standards for physical characteristics and biocompatibility, not through human expert assessment of a "ground truth" like in imaging or diagnostic AI.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and not provided. The testing involves objective physical and chemical measurements against pre-defined standards, not a subjective assessment requiring adjudication among experts.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation. This document pertains to a medical glove.

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

This is not applicable as the device is a medical glove, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is defined by the established ASTM and ISO standards for nitrile examination gloves. These standards specify acceptable ranges and methodologies for evaluating dimensions, physical properties (tensile strength, elongation), freedom from pinholes, powder residue, and biocompatibility.

8. The sample size for the training set

This is not applicable. The device is a physical product (medical glove) and not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

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

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