Search Results

The Nitrile Glove Powder Free White is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is white. The proposed device is non-sterile.

The provided document is a 510(k) summary for the "Nitrile Glove Powder Free White." This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a predicate device already on the market. It primarily focuses on comparing the new device's characteristics and performance to the predicate device and relevant standards, rather than describing a traditional clinical study with human subjects, AI involvement, or ground truth establishment as might be found for more complex diagnostic devices.

Therefore, many of the requested categories are not directly applicable or are not detailed in this document.

Here's an analysis based on the provided text:

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

The acceptance criteria are established by various ASTM and ISO standards, and the reported device performance indicates compliance with these standards.

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

The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for tensile strength or holes). It refers to compliance with standards like ASTM D5151 and D6319, which would typically define such sample sizes. The data provenance is implied to be from laboratory testing performed by "Haining Medical Products Co., Ltd." or their designated testing facilities in China (as per the submitter's address). The tests are non-clinical tests, not studies with human subjects.

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 submission. The "ground truth" for medical gloves is established by objective physical and chemical testing against recognized international and national standards (e.g., ASTM, ISO) for properties like tensile strength, elongation, freedom from holes, powder content, and biocompatibility. There are no human "experts" establishing a "ground truth" in the clinical sense for this product's performance.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where subjective interpretation of images or other data by multiple readers is involved. For medical glove testing, objective measurements against pre-defined thresholds from standards are used.

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 document concerns a physical medical device (nitrile gloves), not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant.

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

This is not applicable. This document concerns a physical medical device (nitrile gloves), not an algorithm.

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

The "ground truth" for the device's performance is established by objective measurements and laboratory tests against the specific requirements and methodologies outlined in the referenced standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5). For example, "freedom from holes" is determined by a specific test method in ASTM D5151, not by expert consensus or pathology. Biocompatibility is assessed through standardized in-vitro and in-vivo tests as per ISO 10993.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms.

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

This is not applicable as there is no training set mentioned or relevant to this device's submission.

Ask a specific question about this device

The Nitrile Glove Powder Free Black is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is black. The proposed device is non-sterile.

This document is a 510(k) summary for a Nitrile Glove Powder Free Black, classifying it as a Class I medical device. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K171422).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria & Reported Device Performance:

The document presents a "Technological Characteristic Comparison Table" (Table 1), "Device Dimensions Comparison" (Table 2), "Performance Comparison" (Table 3), and "Safety Comparison" (Table 4) where the proposed device's performance is compared against the predicate device and relevant standards. This serves as the primary method to demonstrate that the proposed device meets the acceptance criteria (substantial equivalence to the predicate and compliance with recognized standards).

2. Sample Sizes and Data Provenance (for test set, if applicable):

The document states, "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, it does not specify the sample sizes used for these non-clinical tests (e.g., how many gloves were tested for Freedom from Holes, Tensile Strength, etc.).

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for the data, other than the submitting company being located in China. Given the nature of these tests (bench testing for physical and chemical properties), they would typically be prospective tests performed on samples of the manufactured device.

3. Number of Experts and Qualifications (for ground truth of test set):

This information is not applicable to this submission type. Ground truth in this context typically refers to clinical diagnosis or pathology readouts. For a Class I medical device like a glove, the "ground truth" is adherence to physical/chemical standards and biocompatibility tests, not expert clinical interpretation. The "experts" would be the personnel in the testing laboratories conducting the ASTM and ISO standard tests. Their qualifications are inherent in their ability to perform these accredited tests.

4. Adjudication Method (for test set):

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic accuracy, where multiple human readers interpret data, and a consensus mechanism is employed to establish ground truth or resolve discrepancies. For physical and biocompatibility testing of a medical glove, objective laboratory test results are obtained, and no such adjudication is necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not done and is not relevant for this type of device. MRMC studies are typically performed for diagnostic imaging devices to assess the impact of AI on reader performance.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was not done and is not applicable. This is a physical product (a glove), not an algorithm or AI-powered device.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is established through:

• Compliance with recognized international and national standards: ISO 10993-10, ISO 10993-5, ASTM D6124-06, ASTM D5151-06, and ASTM D6319-10. These standards define the acceptable performance characteristics for medical gloves.
• Comparison to a legally marketed predicate device (K171422): Demonstrating that the proposed device's characteristics (dimensions, physical properties, material, biocompatibility) are substantially equivalent to a device already cleared by the FDA.

8. Sample Size for the Training Set:

This information is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device.

Ask a specific question about this device