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The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. The gloves are single use only, supplied in a nonsterile state, and come in six (6) sizes: XS, S, M, L, XL, and XXL. The gloves are made of Nitrile Butadiene Rubber, designed, and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Their physical and performance characteristics meet all requirements of ASTM D6319-10. The gloves are powder-free and meet the requirements of ASTM D6124-06. No powder is used during any stage of manufacturing. Rather, the gloves are manufactured using online chlorination - a process wherein the examination gloves are dipped in a dilute chlorine solution to reduce surface friction. More specifically, through the chlorination reaction, the compound is stabilized and further cross-linked and the gloves' surface becomes hardened and smooth, thereby providing the gloves with good donning properties. The gloves then are removed from the chlorination solution and neutralized in an aqueous ammonia solution and washed until any residual chlorine is removed, resulting in the gloves' surface pH being similar to that of water. Once the wash process is completed, the reactive material is removed, thus ceasing the chlorination process.

The document describes the non-clinical testing and acceptance criteria for the "Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove" (K190159). The study aimed to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (K082125).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on ASTM D6319 versions: The "Technological Characteristic Comparison Table" lists "Meets ASTM D6319-00" for both predicate and proposed devices under "Physical Property." However, the "Summary of Non-Clinical Testing" for the proposed device explicitly lists "ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application" as a standard it conforms to. It's likely that compliance with D6319-10 (a newer version) supersedes or includes requirements from D6319-00.

2. Sample size used for the test set and the data provenance

The document refers to non-clinical testing based on various ASTM and ISO standards for medical gloves. These standards typically involve specific sampling plans and test methods for performance, water tightness, and biocompatibility.

• Sample Size: The exact sample sizes for each test within the ASTM and ISO standards are not explicitly stated in this summary. These standards define the required sample sizes for tests such as water tightness (e.g., AQL levels), tensile properties, and force at break. For biocompatibility studies (ISO 10993), specific numbers of animal models are used per test, but are not detailed in this summary.
• Data Provenance: The studies are described as "non-clinical testing" conducted to demonstrate conformity with recognized international standards (ASTM and ISO). This implies laboratory testing of the manufactured gloves. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, beyond it being a submission for premarket notification K190159 for a newly manufactured device.

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

Not applicable to this device submission. This document pertains to the physical and biological performance testing of a medical exam glove, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the objective measurement of the glove's properties against established standard specifications (e.g., tensile strength, freedom from holes, biocompatibility).

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

Not applicable. As noted above, this involves objective physical and chemical testing against established standards, not interpretation by human adjudicators.

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

Not applicable. This is not an AI-enabled diagnostic device.

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

Not applicable. This is not an algorithm or AI-based device.

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

The ground truth is established by objective measurements and chemical/biological testing against pre-defined, standardized acceptance criteria outlined in the referenced ASTM and ISO standards (e.g., ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, ISO 10993-10, ISO 10993-11). For example, the "ground truth" for water tightness is the absence of holes when tested using the specified method; for biocompatibility, it's the lack of specified adverse biological responses in animal models.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device that requires a "training set."

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

Not applicable. No training set is used for this type of medical device submission.

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