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The Nitrile Examination Gloves is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The proposed device, Nitrile Examination Gloves (Blue, Violet) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Violet. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.

This document describes the performance testing for Nitrile Examination Gloves (Blue, Violet). Here's a breakdown of the acceptance criteria and study details:

Acceptance Criteria and Reported Device Performance

Device: Nitrile Examination Gloves (Blue, Violet)
Purpose: Non-sterile disposable device worn to prevent contamination between patient and examiner.

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The Powder free Nitrile Examination Gloves (Blue, White, Cobalt Blue) 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, Powder Free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Violet Blue, White, and Cobalt Blue.

The proposed device is not provided as sterilized

This document is a 510(k) Pre-Market Notification for Powder free Nitrile Examination Gloves. The acceptance criteria and the study proving the device meets these criteria are detailed in the "Performance and Physical Specifications" table (Table 2) on page 5, and the "Performance Comparison" table (Table 3) on pages 6-7, supported by non-clinical bench tests.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the test set for each specific test (e.g., tensile strength, pinholes). However, the testing was conducted according to recognized ASTM and ISO standards, which typically specify sampling plans. The data provenance is from non-clinical bench tests performed to verify the device's compliance with design specifications and relevant standards. The country of origin of the data is implied to be related to the manufacturer in Vietnam or the testing facilities they utilized. The studies are prospective as they were specifically conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable for this type of device and study. The "ground truth" for performance of examination gloves is established by quantitative measurements according to standardized test methods (ASTM and ISO standards), not by expert opinion.

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

Not applicable. As described above, performance is determined by objective measurements using standardized test methods.

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 device is an examination glove, not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable. This device is an examination glove, not an algorithm.

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

The "ground truth" for the performance of the examination gloves is based on established industry standards and test methods (ASTM D6319-15, ASTM D5151-06, ASTM D6124-17, ISO 10993-10:2010, ISO 10993-5:2009). These standards define the acceptable physical properties, barrier integrity, and biocompatibility of medical examination gloves.

8. The sample size for the training set

Not applicable. This device is an examination glove, not a machine learning model that requires a training set.

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

Not applicable. There is no training set for this device.

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The NITRILE EXAMINATION GLOVES (Blue, Violet Blue, \Vhite) 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, NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) includes variations of different size and color. The colors of the proposed device are Blue, and White.

The document describes the K202402 Nitrile Examination Gloves. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document explicitly states that "The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319." and that the bench tests "demonstrated that the proposed device complies with the following standards".

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

The document does not specify the exact sample sizes for each test that was performed. It generally refers to "bench tests" for physical properties and "biocompatibility tests".

• Provenance: No specific country of origin is mentioned for the test data itself, beyond the manufacturer being in China. The study is non-clinical bench testing, not human data.

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

Not applicable. This is a medical glove, and the "ground truth" for its performance is established by adherence to recognized international standards (ASTM, ISO) through objective physical and biocompatibility testing, not expert consensus on interpretations of complex medical images or outcomes.

4. Adjudication method for the test set

Not applicable, as the tests are objective measurements against standards.

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 a medical glove, not an AI-powered diagnostic device.

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

Not applicable. This is a medical glove, not an algorithm.

7. The type of ground truth used

The ground truth used for performance evaluation is defined by international consensus standards for medical gloves (ASTM D6319-15, ASTM D5151-06, ASTM D6124-17) and biocompatibility testing standards (ISO 10993-10:2010, ISO 10993-5:2009). The device is tested against the specified parameters and thresholds outlined in these standards.

8. The sample size for the training set

Not applicable. This is a physical medical device (gloves), not an AI algorithm requiring a training set.

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

Not applicable. This is a physical medical device (gloves), not an AI algorithm.

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