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The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided text describes the acceptance criteria and performance of a Nitrile Patient Examination Glove, not an AI-powered medical device. Therefore, the questions related to AI device performance metrics, such as ground truth, expert consensus, MRMC studies, and training/test sets, are not applicable in this context.

This document is a 510(k) Premarket Notification for a Class I medical device (nitrile examination glove), which establishes substantial equivalence to a predicate device based on physical and performance characteristics, and biocompatibility.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established ASTM and ISO standards for medical gloves. The reported device performance is compared against these standards and the predicate device.

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The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided document is a 510(k) Summary for a medical device called "Nitrile Patient Examination Glove." It outlines the device's characteristics, intended use, and comparison to a predicate device, along with non-clinical performance testing.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample sizes used for the test set and the data provenance:
   The document does not specify exact sample sizes for each test. However, it indicates compliance with recognized standards such as ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (Reapproved 2017), ISO 10993-10:2010, and ISO 10993-5:2009. These standards inherently define appropriate sampling plans for testing.
   The data provenance is from non-clinical tests conducted to verify design specifications. The company, Jiangxi Zhonghong Pulin Medical Products Co.,Ltd., is located in China. The nature of these tests (e.g., laboratory testing of material properties) implies prospective data collection as part of the device development and regulatory submission process.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as the evaluation relies on established standardized test methods (e.g., ASTM, ISO standards) for material properties and biocompatibility, rather than expert interpretation of a diagnostic output. The "ground truth" is determined by the objective results of these standardized tests against their defined pass/fail criteria.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This is not applicable. The tests performed are objective, quantitative or qualitative measurements governed by international standards, not subjective interpretations requiring adjudication.

4. 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. The device is a patient examination glove, not an AI-powered diagnostic or assistive SaMD (Software as a Medical Device). Therefore, MRMC studies are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This is not applicable. The device is a physical medical glove, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for this device is based on objective, standardized test results against the specifications outlined in relevant ASTM and ISO standards for physical properties, barrier integrity, and biocompatibility. For example:

   • Physical properties (Tensile Strength, Elongation): Measured values compared against minimum requirements specified in ASTM D6319.
   • Freedom from Holes: Determined by testing in accordance with ASTMD5151, with an Acceptance Quality Limit (AQL) of 2.5.
   • Powder Content: Measured against requirements of ASTM D6124.
   • Biocompatibility (Irritation, Sensitization, Cytotoxicity): Determined by laboratory assays compliant with ISO 10993-10 and ISO 10993-5, where the outcome is classified as "not an irritant," "not a sensitizer," or "not cytotoxic."

7. The sample size for the training set:
   This is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

8. How the ground truth for the training set was established:
   This is not applicable for the same reason as above.

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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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