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The Vinyl Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

This document is a 510(k) Premarket Notification for Vinyl Patient Examination Gloves, asserting substantial equivalence to a predicate device (K163168). The acceptance criteria and supporting studies are primarily focused on physical and chemical performance standards for medical gloves, rather than AI/algorithm-based criteria.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTMD5151, and ASTMD5250. The proposed device is non-sterile.

This document is a 510(k) Pre-Market Notification for a Vinyl Patient Examination Glove, asserting substantial equivalence to a predicate device. It primarily focuses on demonstrating that the new device meets established standards for medical examination gloves.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by recognized industry standards, and the reported device performance is presented as compliance with these standards or specific measured values.

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

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many gloves were tested for tensile strength, elongation, or freedom from holes). However, it refers to industry standards (ASTM D5151, ASTM D5250, ASTM D6124) which inherently define sampling plans for these tests. For instance, ASTM D5151 specifies an Acceptance Quality Limit (AQL) of 1.5, which implies a specific sampling size based on lot size for hole detection.

The data provenance is not explicitly stated in terms of country of origin for the testing itself, but given the submitter's address in China, it's reasonable to infer the testing took place there. The studies are retrospective in the sense that they are post-manufacturing tests performed on the finished product according to established standards.

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

This information is not applicable to this type of device and study. The "ground truth" for Vinyl Patient Examination Gloves is primarily established by objective, quantifiable physical and chemical properties and biological safety assessments derived from standardized laboratory tests. There is no subjective assessment by medical experts required to determine if a glove has a specific tensile strength or is free from holes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., image reading) where multiple experts might disagree on an assessment. For objective laboratory tests, the results are quantitative and do not require expert adjudication in this manner.

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 is not applicable. This is a submission for an examination glove, which is a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and assessment of AI assistance for human readers are irrelevant.

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

This is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on objective, quantitative laboratory measurements and biological testing results as defined by recognized consensus standards (ISO 10993-10, ISO 10993-5, ASTM D6124, ASTMD5151, ASTM D5250). For example:

• Physical Properties: Measured tensile strength and ultimate elongation against specified minimums.
• Freedom from Holes: Determined by standardized water leak tests (e.g., based on ASTM D5151).
• Powder Content: Measured gravimetrically according to ASTM D6124.
• Biocompatibility: Determined by in vitro and in vivo toxicology tests for irritation, sensitization, and cytotoxicity according to ISO 10993 standards.

8. The Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning. The "training" for such devices involves adherence to manufacturing process controls and validated testing methods to ensure consistent product output.

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

This is not applicable as there is no "training set" for this type of device. The ground truth for evaluating the device's performance is established by the specified requirements in the referenced international and ASTM standards.

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The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vinyl Patient Examination Gloves (K182115):

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a "table of acceptance criteria" in the typical sense for a medical device's performance in a diagnostic or therapeutic context. Instead, it compares the proposed device's characteristics and performance against a predicate device and relevant ASTM/ISO standards. Here's a table summarizing the key performance aspects that act as de facto acceptance criteria by demonstrating equivalence to the predicate and compliance with standards:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for tensile strength, or freedom from holes). It refers to compliance with standards like ASTM D5151 for Freedom from Holes, which would dictate sampling plans. The data provenance is retrospective testing of the manufactured medical device components. The company, Ping An Medical Products Co., Ltd., is located in China (Jiangxi Province), indicating the country of origin for the data.

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

This information is not applicable and not provided in the document. The "ground truth" for this device (patient examination gloves) is established through adherence to recognized international and national standards (ASTM, ISO) for physical properties, biocompatibility, and freedom from defects. There isn't a "ground truth" in the diagnostic sense that requires expert consensus on a clinical condition.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to determine a true diagnosis or outcome. For a physical product like examination gloves, compliance with precise measurement and testing standards is the primary method of evaluation.

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 and not provided. This device is a medical glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant.

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

This information is not applicable and not provided. This device is a medical glove, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device relies on:

• Compliance with established industry standards: ASTM D5250, ASTM D5151, ASTM D6124 for physical properties and defect levels.
• Biological safety standards: ISO 10993-10 (irritation, sensitization) and ISO 10993-5 (cytotoxicity) for biocompatibility.
• Comparison to a legally marketed predicate device (K163168) for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device is a physical product, not a machine learning model that requires a training set.

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

This information is not applicable and not provided. As mentioned, there is no training set for this type of device.

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