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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 proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue.

This device submission (K122696) is for Powder-Free Nitrile Examination Gloves (Cool Blue). It is a medical device designed to prevent contamination between patients and examiners. The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards for patient examination gloves.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for freedom from holes, number of animals for biocompatibility). However, it indicates that the tests were conducted according to recognized standards like ASTM D6319, ISO 10993-10, and 21 CFR 800.20. These standards typically define appropriate sampling plans and sample sizes for their respective tests.

The data provenance is retrospective, as the tests were conducted and summarized to demonstrate that the manufactured gloves meet the pre-defined performance standards. The country of origin of the data is not specified beyond where the testing facilities are located, which is also not detailed in the provided text.

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

This submission does not involve expert-established ground truth in the traditional sense of clinical studies. The "ground truth" for this device is based on established industry standards and regulatory requirements (e.g., ASTM D6319, ISO 10993-10, 21 CFR 800.20). These standards themselves were developed through expert consensus within their respective fields, but the submission itself does not detail the specific experts involved in the testing or analysis of the results. The determination of "meets requirements" is based on objective measurements against these standards.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective measurements against pre-defined quantitative or qualitative criteria within the referenced standards. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices where human interpretation is a critical factor, often comparing human performance with and without AI assistance. This device is a medical glove, and its effectiveness is determined by objective physical and biocompatibility properties, not interpretive performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Yes, the studies presented are essentially standalone performance studies. The "device" in this context is the physical glove, and its performance is evaluated against material and physical specifications documented in the referenced standards (ASTM D6319, ISO 10993-10, etc.). There is no "algorithm" or "human-in-the-loop" component to the glove's function that would require a separate evaluation. The tests measure the intrinsic properties of the glove itself.

7. Type of Ground Truth Used:

The ground truth used is based on established industry standards and regulatory requirements.

• Biocompatibility: Standards like ISO 10993-10 define acceptable levels of irritation and sensitization.
• Physical Characteristics: Standards like ASTM D6319 define acceptable dimensions, physical properties (e.g., tensile strength, elongation), freedom from holes (water leak test), and powder residual limits.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML-based device that requires a training set. The "device" is a physical product, and its performance is assessed through traditional engineering and material science testing methods, not through machine learning.

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

Not applicable, as there is no training set for this type of device.

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