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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

PVC films form a barrier to prevent contamination between patient and examiner. The PVC 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. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

This document, K182575, is a 510(k) Premarket Notification for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". As such, it does not contain the type of acceptance criteria and study data typically associated with a "device" in the context of an AI/ML medical device, which would involve performance metrics like accuracy, sensitivity, specificity, and a detailed human-in-the-loop (HITL) study.

This submission is for a Class I medical device (patient examination glove), which, by regulation, has a much lower bar for demonstrating substantial equivalence to a predicate device. The "performance data" here refers to physical and biological characteristics of the glove, not diagnostic or predictive performance.

Therefore, I cannot provide the requested information in the format of AI/ML device studies because the provided document does not pertain to such a device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to manufacturing and material standards, not clinical diagnostic accuracy.

However, I can extract the information relevant to this specific device type and its "studies":

Acceptance Criteria and Device Performance (for a physical medical device: Examination Glove)

Since this is for a physical device, the following points are not applicable or interpreted differently than for an AI/ML device:

2. Sample sizes used for the test set and data provenance: Not explicitly stated as "sample size" in the context of an AI/ML test set. Performance is stated as meeting ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards, which implies specific destructive and non-destructive testing on a representative sample of manufactured gloves. The provenance is internal testing by the manufacturer (Jiangxi Jaysun Medcare Co., Ltd., China). The studies are "non-clinical tests" (physical and biological).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (dimensions, tensile strength, pinholes) is established through standardized laboratory testing methods. Biocompatibility (irritation, sensitization, cytotoxicity) is assessed through lab-based biological assays.

4. Adjudication method for the test set: Not applicable. Standardized test methods do not typically involve human adjudication in the same way an AI/ML diagnostic output would. Outcomes are based on quantitative measurements and biological assay results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical product, not an AI/ML diagnostic tool. Human readers are not involved in its performance evaluation in this manner.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "standalone" performance here refers to the physical attributes and biocompatibility of the glove itself, as tested independently against the standards. There is no algorithm.

7. The type of ground truth used:

   • Physical properties (dimensions, tensile strength, elongation): Established by objective measurements against specified values in ASTM standards.
   • Freedom from Pinholes: Established by standardized leak tests (e.g., water fill test per ASTM D5151).
   • Residual Powder: Established by gravimetric analysis per ASTM D6124.
   • Biocompatibility: Established by standardized biological assays (e.g., ISO 10993-5, ISO 10993-10) using in-vitro and in-vivo models (e.g., L-929 cells, animal models for irritation/sensitization).

8. The sample size for the training set: Not applicable. This device is not an AI/ML product and does not have a "training set" in that sense. The manufacturing process is refined based on quality testing, but there's no data training of a model.

9. How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

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