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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.

Non-sterile, single-use, powder-free nitrile patient examination gloves (blue color), that meet requirements of ASTM D6139-10.

Here's a breakdown of the acceptance criteria and study information for the Linshi Health Nitrile Disposable Exam Gloves, Powder-Free, based on the provided 510(k) summary:

This device is a Class I medical device (patient examination glove), and the submission is for substantial equivalence to a predicate device (ETS Blue Powder Free Nitrile Patient Examination Glove K121947). For such devices, clinical studies and reader studies as typically understood for AI/ML devices are generally not applicable. Instead, the "study" involves demonstrating that the device meets established performance standards.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable for this type of device)

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not explicitly state a "test set" sample size in terms of clinical cases or images, as this is a physical medical device (gloves), not an AI/ML diagnostic or imaging device.
   • Instead, compliance is demonstrated by testing the physical properties of the gloves against established ASTM standards. The ASTM standards themselves specify sampling plans for testing. For example, ASTM D6319-10 (standard for Nitrile Examination Gloves for Medical Application) outlines sampling for tests like dimensions, tensile strength, elongation, and watertightness (pinholes).
   • Data Provenance: Not applicable in terms of country of origin for clinical data. The tests would likely be conducted in a laboratory setting, presumably by the manufacturer or a certified testing facility in China (country of manufacture). The ASTM standards are international benchmarks.
   • Retrospective or Prospective: Not applicable in the context of clinical studies. The testing is performed on manufactured lots of the product.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Not applicable. The "ground truth" for this device is defined by the objective, measurable parameters outlined in the ASTM standards (e.g., specific tensile strength in MPa, elongation percentage, maximum allowable number of pinholes per inspection level). These are not subjective interpretations requiring expert consensus.

3. Adjudication Method for the Test Set:

   • Not applicable. Performance is determined by objective laboratory measurements against set thresholds in ASTM standards, not by human adjudication of subjective assessments.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC study was not done. This type of study is used to evaluate the impact of an AI system on human reader performance for diagnostic tasks. It is not relevant for the evaluation of disposable examination gloves.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • No. This is a physical device, not an algorithm. Standalone performance as typically described for AI is not applicable.

6. The Type of Ground Truth Used:

   • The "ground truth" (or more accurately, the conformance standard) is established by objective, quantitative measurements against international consensus standards (ASTM). These standards define acceptable ranges for physical properties and biocompatibility.

7. The Sample Size for the Training Set:

   • Not applicable. There is no AI algorithm being trained for this device. The manufacturing process is designed to consistently produce gloves that meet the specified standards.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set as understood for AI/ML devices. The "ground truth" or target specifications for manufacturing are established by ASTM standards and validated through quality control testing.

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