Search Results

The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.

The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.

The provided document is a 510(k) premarket notification for Powder-Free Latex Examination Gloves. This type of device is classified as a Class I medical device (21 CFR 880.6250 - Non-Powdered Patient Examination Glove).

The information requested regarding acceptance criteria and a study proving the device meets those criteria typically applies to more complex devices, especially those involving AI/ML components or requiring clinical performance studies to establish safety and effectiveness.

For this specific device (examination gloves), the "study" that proves it meets acceptance criteria is primarily non-clinical testing against established ASTM and ISO standards for physical properties, integrity, and biocompatibility. Clinical studies are explicitly stated as not included in this submission.

Therefore, many of the requested points are not applicable in the context of this 510(k) submission for examination gloves. I will address the applicable points and explicitly state where information is not present or not relevant to this type of device.

Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves (K222612)

For this device, the "acceptance criteria" are defined by compliance with recognized consensus standards (ASTM and ISO). The "study" proving acceptance is the non-clinical testing performed against these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample sizes (e.g., number of gloves) used for each specific non-clinical test. These sample sizes would be specified within the methodologies of the referenced ASTM and ISO standards.
• Data Provenance: The testing was conducted by or on behalf of Guangdong Kingfa Sci.&Tech. Co., Ltd., based in China. The data is from non-clinical laboratory testing, not human subjects, and is inherently retrospective as it was conducted prior to this 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):

• Not applicable. For this type of device, "ground truth" is established by the physical and chemical properties measured against the objective metrics defined in the ASTM and ISO standards, using calibrated equipment and standard laboratory procedures. It does not involve human expert interpretation or consensus comparable to image-based medical device studies.

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

• Not applicable. Adjudication methods are relevant for human-interpretable data where multiple readers might have differing opinions (e.g., medical image interpretation). This submission relies on objective laboratory test 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. MRMC studies are used for evaluating human performance, typically involving AI assistance in diagnostic tasks. This device is an examination glove, not an AI-enabled diagnostic tool. No clinical study was performed.

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

• Not applicable. This device does not have an "algorithm" or standalone AI component. Its performance is measured directly through physical and chemical testing.

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

• The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards. For example, tensile strength measured in MPa, hole detection based on water leak AQL, residual powder in mg/glove, protein content in µg/dm², and ISO 10993 series for biological responses (irritation, sensitization, systemic toxicity) are the "ground truth" metrics.

8. The sample size for the training set:

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

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

• Not applicable due to the absence of a training set.

Ask a specific question about this device

A 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. Gloves that have been tested for use with chemotherapy drugs are not intended to be used as a chemical barrier.

Powderfree Blue Latex Examination Gloves – Tested For Use With Chemotherapy Drugs; Powderfree Natural Latex Examination Gloves - Not Tested For Use With Chemotherapy Drugs

This document is a 510(k) premarket notification letter from the FDA regarding patient examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot answer your request based on the provided text.

Ask a specific question about this device

a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Textured Powder-Free Latex Examination Gloves with Protein Labeling Claim (contains 50 micrograms or less of total water extractable protein per gram), Blue Color

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically Textured Powder-Free Latex Examination Gloves. It is not a study report or clinical trial documentation, and therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter primarily:

• Acknowledges the review of the 510(k) submission (K030583).
• States that the device is substantially equivalent to legally marketed predicate devices.
• Grants permission to market the device, subject to general controls.
• Provides information on regulatory compliance.

The second attachment to the letter, titled "INDICATION FOR USE," describes the intended use of the gloves but does not present any performance data or acceptance criteria for evaluation.

Ask a specific question about this device

A 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, Latex Patient Examination Glove With Protein Labeling Claim. (contain 200 microgram or less of total water extractable protein per gram glove).

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a "Powder-Free, Latex Patient Examination Glove with Protein Labeling Claim."

The text focuses on:

• The FDA's determination of substantial equivalence to a legally marketed predicate device.
• Regulatory classifications and requirements for general controls (registration, labeling, good manufacturing practice).
• Contact information for various FDA offices.
• The intended use of the device.

There is no information within the provided text about:

1. Specific acceptance criteria for device performance.
2. Details of any study conducted to demonstrate the device meets performance criteria (such as sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance).
3. Reported device performance metrics.

The document states a "Protein Labeling Claim: Contains 200 Micrograms or Less of Total Water Extractable Protein Per Gram Glove," which is a characteristic of the device, but it does not present this as an "acceptance criterion" in the context of a performance study with reported results. The 510(k) process primarily assesses substantial equivalence to a predicate device, rather than requiring extensive de novo clinical performance studies for low-risk devices like gloves.

Ask a specific question about this device

The Powder-Free Latex Examination Glove (green) with natural water soluble Vitamin E and Protein Labeling Claim(50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s)to provide a barrier against potentially infectious materials and other contaminants. This device is not intended to be used as a chemical barrier.

Class I powder free latex examination gloves (green) with natural water soluble Vitamin E and protein labeling claim(50 microgram or less), 80L Y Y, non-sterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for "POWDER FREE LATEX EXAMINATIN GLOVES (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS PER GRAM OF GLOVE)".

It's important to note that this is a medical device submission for examination gloves, not an AI/Software as a Medical Device (SaMD) submission. Therefore, many of the typical questions related to AI studies (like MRMC, training set details, expert qualifications for AI ground truth) are not applicable to this type of device. The focus here is on physical and chemical performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Textured Powder-Free Latex Examination Gloves with Protein Claim ( Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram), Green Color

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically "Textured Powder-Free Latex Examination Gloves with Protein Claim". It primarily addresses the device's substantial equivalence to a predicate device and its regulatory classification.

The letter does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria. It mentions protein claims (containing 50 micrograms or less of total water extractable protein per gram) but it doesn't describe the testing or study conducted to verify this claim.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

A 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, Latex Examination Glove coated with Aloe Vera gel.

The provided text is a 510(k) clearance letter from the FDA for a medical device, specifically a "Powder-Free Latex Examination Glove Coated with Aloe Vera Gel." This type of document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI or diagnostic device.

The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing related to basic safety and effectiveness (e.g., integrity, biocompatibility for gloves). It does not typically involve the kind of elaborate clinical studies or AI model evaluation that would generate the data you're asking for.

Therefore, I cannot provide the requested information based on the input text. The text does not describe:

• Acceptance criteria for an AI device.
• A study proving the device meets those criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Details about experts or ground truth establishment.
• MRMC studies or standalone algorithm performance.

Ask a specific question about this device

A 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. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.

Powder Free Examination Gloves are formulated using latex and have colorants. These gloves are offered non-sterile.

The provided text describes the safety and effectiveness of POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS (K020818) by Allegiance Healthcare Corporation. This is a medical device, specifically a patient examination glove, and the document outlines its performance characteristics against established standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test. The data provenance is implied to be from internal testing conducted by Allegiance Healthcare Corporation. There is no information provided about the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The tests described are laboratory-based performance tests against established standards (e.g., ASTM, FDA regulations), not tests that require expert interpretation of results to establish ground truth in the way clinical diagnostic devices might.

4. Adjudication method for the test set

This information is not applicable as the tests described are objective, laboratory-based physical and chemical property assessments, not subjective human-interpreted data that would require an adjudication process.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or other AI-assisted diagnostic tools. The gloves are a physical medical device, and their performance is evaluated through standardized laboratory tests. There is no AI component mentioned.

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

Not applicable. This device is a physical product (gloves) and not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective, standardized laboratory test methods and established specifications set by regulatory bodies (e.g., 21 CFR §800.20) and industry standards (e.g., ASTM D3578-01, ASTM 5712-99). These standards define acceptable physical properties, chemical characteristics (like protein levels), and biological safety (skin irritation, sensitization).

8. The sample size for the training set

Not applicable. This device is not an AI system or algorithm that requires a training set.

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

Not applicable. Since there is no training set, there is no ground truth establishment for one.

Ask a specific question about this device

a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Tested for Use with Chemotherapy Drugs

Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Use with Chemotherapy Drugs Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram

The provided text is a U.S. FDA 510(k) clearance letter for "Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Use with Chemotherapy Drugs". This document is a regulatory communication and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

Therefore, I cannot provide the requested information based on the given input. The document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed, but it does not detail the technical studies that would typically define acceptance criteria and performance.

Ask a specific question about this device

a disposable device intended for medical purpose that is worn on the examiner's a disposable do not internation belween patient and examiner. Tested for Use with Chemotherapy Drugs.

Powder-Free Latex Examination Gloves with Aloe-and Protein Claim, Tested for Powderfriee Latex Cammation Color Color Color Color Color Color on or less on water Extractable Profess per gram

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) substantial equivalence determination letter from the FDA for "Powder-Free Latex Examination Gloves Green, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram, Tested For Use with Chemotherapy Drugs."

This type of letter primarily indicates that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It refers to general controls and regulations but does not detail specific performance acceptance criteria or study results in the way that would typically be found in a study report or clinical trial summary.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device