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The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The powder free Nitrile Examination glove is a disposable Class 1 medical device made of Nitrile rubber, and is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The principal operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves for medical Application.

The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs" (K213306), a Class I medical device.

Note: The document is for a medical device (gloves), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study components for AI/SaMD (e.g., ground truth establishment by experts, MRMC studies, effect size of AI assistance, training set details) are not applicable or provided in this context. The information provided focuses on the physical and chemical performance of the gloves.

Here's an breakdown of the available information regarding acceptance criteria and device performance:

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

The primary acceptance criteria are based on various ASTM and ISO standards for examination gloves and chemotherapy drug permeation.

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

• ASTM D5151 (Water tightness): 200 pieces of gloves.
• ASTM D6319 (Physical Dimensions): 13 pieces for each size (total 65 pieces: S, M, L, XL, and presumably X-Small from the comparison table, although the specific breakdown adds up to 5 sizes * 13 = 65).
• ASTM D412 (Physical Properties): 13 pieces for each size (total 65 pieces).
• ASTM D6124 (Residual Powder Content): 5 pieces for each size (total 25 pieces).
• ISO 10993-10 (Skin irritation/sensitization) & ISO 10993-5 (Cytotoxicity): The specific number of test subjects (e.g., guinea pigs for sensitization, L929 cells for cytotoxicity) is not explicitly stated, but standard animal models and cell lines are typically used.
• ASTM D6978-05 (Chemotherapy Drug Permeation): The specific sample size for each drug permeation test is not explicitly stated in this summary. However, these are bench tests.

Data Provenance: The document does not specify the country of origin for the testing data beyond the manufacturer being in China. The tests are "Performance Testing (Bench)" and "Biocompatibility Testing," indicating they are laboratory-based studies. The nature of these tests means they are prospective in the sense that the testing was conducted specifically to evaluate the performance of these gloves against the specified standards.

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

This section is not applicable as the device is a physical medical glove and not an AI/Software as a Medical Device (SaMD) that would rely on expert interpretation of medical images or data for ground truth. The "ground truth" for these tests is the objective measurement against established physical/chemical standards (e.g., a hole detected by water, a specific tensile strength value, a chemical permeation time).

4. Adjudication method for the test set

This is not applicable. The tests are objective measurements against established standards, not subjective interpretations requiring reader adjudication.

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 device (glove) that does not involve human readers interpreting data or AI assistance.

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

This is not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

The ground truth used for these studies is based on accepted international and national consensus standards for medical gloves and their performance (ASTM D5151, ASTM D6319, ASTM D412, ASTM D6124, ISO 10993-10, ISO 10993-5, and ASTM D6978-05). It is not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic medical device. It's objective measurement against defined physical and chemical criteria.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI model that requires a training set.

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

This is not applicable for the reasons stated above.

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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 (white, yellow) that meets all of the requirements of ASTM standard D 5250-0084.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is stated and noting areas where the information is not present:

Acceptance Criteria and Device Performance

Study Information

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

   • Sample size: Not explicitly stated. The document refers to meeting standards (ASTM, FDA) which would imply a defined sample size within those standards, but the specific quantity tested for each characteristic is not provided in this summary.
   • Data provenance: Not explicitly stated. The studies are non-clinical, likely conducted by the manufacturer or a third-party lab to demonstrate compliance with the referenced ASTM and ISO standards. The country of origin for the data (beyond the manufacturer's location in China) is not mentioned. It can be inferred that these are prospective tests performed on the device.

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

   • Not applicable/Not stated. For this type of device (patient examination gloves) and the tests conducted (physical and biocompatibility), "experts" in the sense of clinical reviewers establishing ground truth is not typically relevant. The ground truth for these tests is defined by the objective measurement criteria within the ASTM and ISO standards (e.g., maximum allowable pinholes, specific tensile strength values, observed skin reactions in animal models).

3. Adjudication method for the test set:

   • Not applicable/Not stated. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of medical images or data is involved to establish a consensus ground truth. For the physical and biocompatibility testing of gloves, the results are objectively measured against predefined criteria in the standards.

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:

   • Not applicable. This device is a physical patient examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance metrics are not relevant.

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

   • Not applicable. This device is a physical product, not an algorithm, so standalone performance in the context of AI is not relevant.

6. The type of ground truth used:

   • Objective Measurement/Standard Compliance: The ground truth for the performance criteria (dimensions, physical properties, freedom from pinholes, powder residual) is established by the specific, objective measurement criteria and threshold values defined within the ASTM standard D 5250-00e4 and 21 CFR 800.20.
   • Biological Response in Models: For biocompatibility, the ground truth is based on the observed biological responses in the animal models (rabbits for skin irritation, guinea pigs for dermal sensitization) according to the protocols outlined in ISO10993-10. "Passing" the test means the observed reaction falls below predefined thresholds for irritation or sensitization.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064.

The provided document describes the "Powder Free Vinyl Patient Examination Gloves, white (non-colored)" and its premarket notification (510(k)) summary. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study of device performance against specific acceptance criteria using a test set. This type of submission relies on established standards and non-clinical testing.

Here's an analysis of the available information based on your requested categories:

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 sizes used for the testing mentioned (e.g., for dimension, physical properties, pinholes, powder residual, or biocompatibility). It only indicates that the device "Meets" the respective standards. The data provenance is not specified, but the device manufacturer is ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD in China. The testing would have been conducted by or for this company. This testing would be considered prospective, as it's conducted to demonstrate compliance for a new device.

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 as the device's performance is assessed against established ASTM and CFR standards, not through expert consensus on a subjective test set. The standards themselves define objective metrics. For biocompatibility, animal models (rabbits and guinea pigs) were used, not human experts to establish "ground truth" in the way one would for image interpretation, for example.

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

Not applicable. Device performance is measured directly against technical standards, not through expert adjudication of subjective results.

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 a disposable medical glove, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

This concept is not applicable to a physical medical device like a glove. The "standing alone" performance refers to the device's inherent characteristics as measured against specified standards.

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

The "ground truth" for evaluating the performance of these gloves is defined by:

• Established ASTM Standards: These provide quantitative and qualitative specifications for dimensions, physical properties (e.g., tensile strength, elongation), and powder residual.
• Regulatory Standards (21 CFR 800.20): Specifically for freedom from pinholes, which dictates an Acceptable Quality Level (AQL) for water leak testing.
• Biocompatibility Standards (ISO10993-10): These guide the animal testing for primary skin irritation and dermal sensitization. The "ground truth" for these tests is the observed biological response in the animal models according to the standard's interpretation guidelines (e.g., absence of irritation).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device. The physical characteristics and biological safety of gloves are determined through standardized testing, not machine learning or algorithm training.

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

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

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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.

This document is a 510(k) Premarket Notification summary for medical gloves, not a study of an AI device. As such, it does not contain the information requested in your prompt regarding AI device acceptance criteria and study details.

However, I can extract the relevant information about the device performance and acceptance criteria for the medical gloves as presented in this document.

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

Regarding the AI-specific questions (2-9), this document does not contain that information because it pertains to a medical glove, not an AI device.

Ask a specific question about this device