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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

This document describes the acceptance criteria and performance of the "Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color" (K152720) in comparison to a predicate device (K120970) to establish substantial equivalence for FDA 510(k) clearance.

1. Table of Acceptance Criteria and 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 explicitly state the sample size used for the test set for each specific characteristic. It generally refers to compliance with ASTM standards, which would imply that testing was conducted according to the sampling plans defined within those standards.

The provenance of the data is not specified beyond the manufacturer being located in China (Xingda Medical Products Co., Ltd., Luannan County, Tangshan City, Hebei Province, China). The studies are non-clinical performance tests. It is implied these are prospective tests conducted by the manufacturer to demonstrate compliance with the relevant standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as the device is a patient examination glove, and the acceptance criteria are based on objective, standardized physical and chemical properties (e.g., dimensions, tensile strength, pinhole detection, biocompatibility tests). Ground truth is established by standardized testing protocols and measurements, not by expert consensus or interpretation in the way it would be for a diagnostic imaging device.

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

This information is not applicable for this type of device and performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed for subjective assessments or to resolve discrepancies in diagnoses.

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:

This information is not applicable. The device is an examination glove, not an AI-assisted diagnostic or medical imaging device that would involve human readers or AI.

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

This information is not applicable. The device is an examination glove, not an algorithm, so standalone algorithm performance is not relevant.

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

The ground truth for the performance of the examination gloves is based on objective measurements and laboratory tests according to recognized international and US standards (ASTM D6319-10, ASTM D6124-06, 21 CFR 800.20, ISO 10993-10:2010). For example:

• Dimensions: Measured values compared to standard ranges.
• Physical Properties (Elongation, Tensile Strength): Measured values compared to standard minimums/ranges.
• Freedom from Pinholes: Determined by water leak tests, with acceptance based on Acceptable Quality Level (AQL) defined in standards.
• Powder Residual: Gravimetric measurement compared to a maximum limit.
• Biocompatibility: In-vivo assays (rabbits, guinea pigs) to assess irritation and sensitization, with outcomes interpreted against established toxicological criteria as "Passes" or "Not irritant/sensitizer."

8. The sample size for the training set:

This information is not applicable. The device is an examination glove, which does not involve machine learning or AI models that would require a "training set."

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

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

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