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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and study information for K101664, based on the provided text:

Reported Device: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)

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 sample sizes used for testing each characteristic (e.g., number of gloves tested for pinholes or dimensions). It only states that the device "Meets" the specified standards.

The data provenance is not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for a Class I device like examination gloves, where performance standards are well-established.

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

This information is not applicable to this submission. For examination gloves, the "ground truth" is typically defined by adherence to published ASTM and FDA standards, which involve objective measurements and tests rather than expert interpretation of complex data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where there is subjective interpretation of data (e.g., medical imaging) which necessitates a consensus among experts. For objective measurements of glove properties, such a method is not relevant.

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. This device is a physical product (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study is irrelevant.

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

This information is not applicable. As mentioned, this is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established objective standards and test methods. Specifically:

• ASTM D 5250-06': Standard specification for vinyl examination gloves for medical application, covering dimensions, physical properties, and powder amount.
• 21 CFR 800.20: FDA regulation for freedom from pinholes (water leak test).
• ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train an AI algorithm. This device is not an AI algorithm. The manufacturing process for gloves involves quality control checks, but this is distinct from an AI training set.

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

This information is not applicable. As this is not an AI device, there is no "training set" in the AI context, and thus no ground truth to be established for it. The product's compliance is directly assessed against the outlined standards.

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Powder free vinyl 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.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and study information for the K101663 device, structured as requested:

Acceptance Criteria and Device Performance

Study Information

This submission is for a Class I medical device (Patient Examination Glove) and relies on non-clinical testing for substantial equivalence. Clinical trials are typically not required for such devices.

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for pinholes, number of rabbits/guinea pigs for biocompatibility). It generally states that the device "meets requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." These standards inherently define the sample sizes and testing methodologies required.
   • Data Provenance: The tests are performed according to international and US standards (ASTM, 21 CFR, ISO). The manufacturer is based in China. The specific location where the testing was conducted is not explicitly stated, but it would have been conducted by a qualified testing laboratory. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

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

   • For this type of device, "ground truth" is established by adherence to standardized testing protocols. The "experts" are the trained technicians and scientists performing the tests in certified laboratories, who are qualified to execute the specific ASTM, CFR, and ISO standards (e.g., performing physical property tests, waterleak tests for pinholes, and conducting biocompatibility studies). The document does not specify the number or detailed qualifications of these individuals but implies they are competent to conduct tests according to the cited standards.

3. Adjudication method for the test set:

   • Not applicable in the conventional sense for this type of non-clinical testing. The "adjudication" is inherent in whether the test results comply with the specified pass/fail criteria outlined in the standards (ASTM, 21 CFR, ISO). There is no "consensus" among multiple readers/experts in interpreting results for patient examination gloves; rather, there is a direct measurement against defined thresholds.

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:

   • No MRMC comparative effectiveness study was done. This type of study is irrelevant for a patient examination glove, which is a physical barrier device, not an interpretative diagnostic or assistive AI tool.

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

   • Not applicable. There is no algorithm or AI component in this device. Performance is measured against physical and chemical properties.

6. The type of ground truth used:

   • Standards-based measurement: The "ground truth" is defined by the objective pass/fail criteria established within the referenced national and international standards (ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO10993-10). For example, for "Freedom from pinholes," the ground truth is simply whether the glove passes the waterleak test according to 21 CFR 800.20's AQL (Acceptable Quality Level). For biocompatibility, the ground truth is the biological response (e.g., no primary skin irritation, no dermal sensitization) as assessed by standard animal models per ISO10993-10.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or AI, so there is no "training set." The product is manufactured and then tested against established quality control standards.

8. How the ground truth for the training set was established:

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

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