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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all current specifications listed under the ASTM D6319-19 (2023), Standard Specification for Nitrile Examination Gloves for Medical Application and comply with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978-05. The powder-free gloves are made from Nitrile (NBR) latex and are green in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only. The product is not manufactured using natural rubber latex.

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large.

This document is a 510(k) clearance letter for medical examination gloves and contains no information about an AI/ML powered device. Therefore, it's impossible to extract the requested information related to acceptance criteria, study details (sample sizes, data provenance, expert ground truth), MRMC studies, or standalone algorithm performance.

The provided text focuses on the performance characteristics of gloves (e.g., resistance to chemotherapy drugs, physical dimensions, biocompatibility) and their substantial equivalence to a predicate device.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL, Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves:

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 each specific test (e.g., number of gloves tested for length, width, thickness, etc.). However, the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.

• Provenance: This information is not directly stated. The tests were conducted according to international standards (ASTM and ISO). The manufacturing company is Lingshi Hongruida Health Protection Technology Co., Ltd. located in Jinzhong, Shanxi, China. It is highly probable that the testing was performed in a laboratory either in China or an accredited facility capable of performing these international standard test methods. The study appears to be retrospective as it involves the testing of a finished device against established performance criteria.

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

This information is not applicable. The device is a physical product (nitrile gloves), and its performance is evaluated against objective, measurable criteria defined by established engineering and biological safety standards (ASTM and ISO), not subjective expert interpretation of medical images or patient data. The "ground truth" is derived from direct measurements and laboratory analyses, not expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable. As the testing involved objective physical and chemical performance standards, there was no need for expert adjudication. The results were quantifiable measurements against pre-defined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices involving human interpretation of medical data (e.g., radiologists reading images). This product is a medical glove, and its effectiveness is determined through standardized physical, chemical, and biological testing.

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

Yes, the studies conducted are standalone performance evaluations of the physical glove itself, without any human-in-the-loop component in the evaluation of its core performance characteristics (e.g., tensile strength, resistance to chemical permeation, cytotoxicity). The testing directly measured the attributes of the glove.

7. The Type of Ground Truth Used:

The ground truth for this device's performance evaluation is based on established objective technical standards and laboratory measurements. Specifically:

• Physical properties (length, width, thickness, tensile strength, elongation) are measured directly according to ASTM D6319-19 and ASTM D412-16(2021).
• Chemical resistance (chemotherapy drug permeation) is measured according to ASTM D6978-05 (Reapproved 2019).
• Biocompatibility (skin sensitization, irritation, cytotoxicity, systemic toxicity) is evaluated through laboratory tests following ISO 10993 series standards.
• Freedom from holes is evaluated by ASTM D5151-19.
• Powder residue is evaluated by ASTM D6124-06 (Reapproved 2022).

8. The Sample Size for the Training Set:

This information is not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would involve statistical sampling typical for medical device production.

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

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

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The 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.

The glove was tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2023).

The subject device is single use, disposable and non-sterile gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder free, ambidextrous with beaded cuff, Blue/Black colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in six sizes: XS, S, M, L, XL, XXL.

This FDA 510(k) summary describes the acceptance criteria and the study results for the Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242936).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Black Gloves:
Carmustine: 22.6 min
Cisplatin: >240 min
Cyclophosphamide: >240 min
Dacarbazine: >240 min
Doxorubicin HCL: >240 min
Etoposide: >240 min
Fluorouracil: >240 min
Methotrexate: >240 min
Paclitaxel: >240 min
Thiotepa: 35.6 min
Fentanyl Citrate: >240 min |
| ISO 10993 Part 10-2021 - Biocompatibility | | | |
| Skin Sensitization Testing | Skin Sensitization Testing | Under the conditions of the study, the device is not a sensitizer | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. |
| ISO 10993 Part 23-2021 - Biocompatibility | | | |
| Skin Irritation Testing | Skin irritation Testing | Under the conditions of the study, the device is not an irritant | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.0 for the SC and SO test article extracts, respectively. |
| ISO 10993-5:2009 - Biocompatibility | | | |
| Cytotoxicity testing | Cytotoxicity testing | No Cytotoxicity reactivity (note: text says "No Cytotoxicity reactivity" but result section shows some initial toxicity addressed by further testing) | The test article extract showed evidence of causing severe cell lysis or toxicity. Toxicity concerns was addressed by Acute Systemic Toxicity testing. |
| ISO 10993-11:2017 - Biocompatibility | | | |
| Acute systemic toxicity study | Acute systemic toxicity study | Subject showed no adverse biological reaction | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. |

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

The document does not explicitly state the sample sizes for the test sets for each specific test (e.g., how many gloves were tested for length, how many for water leak). However, the standard ASTM D6319-19(2023) and other listed standards would define the required sample sizes for each test to ensure statistical validity.

The data provenance is not explicitly stated in terms of country of origin of the data or retrospective/prospective. However, the tests are "non-clinical tests" conducted to verify design specifications and conform to international and national standards (ASTM, ISO). This suggests the data was generated through controlled laboratory testing following these specified methodologies.

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

This device is a medical glove, and its performance evaluation primarily relies on objective, standardized laboratory tests against defined physical, chemical, and biological endpoints, not subjective expert assessment of images or clinical cases. Therefore, the concept of "experts establishing ground truth for a test set" as typically understood in AI/imaging studies does not apply here. The "ground truth" for these tests is the quantitative measurement results compared to the established thresholds defined by the standards.

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

Not applicable. As mentioned above, the evaluation relies on objective analytical tests rather than subjective human assessment requiring 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:

Not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for the performance evaluation of these gloves is based on objective measurements and chemical analysis as defined by the referenced ASTM and ISO standards. For example:

• Physical properties (length, width, thickness, tensile strength, elongation): Measured values compared to a numerical range or minimum defined by ASTM D6319.
• Freedom from holes (water leak test): Objective criteria (AQL 2.5) for defect detection.
• Powder residue: Quantitative measurement (Max 2mg/glove).
• Chemical permeation (chemotherapy drugs and Fentanyl Citrate): Directly measured breakthrough detection time (BDT) in minutes, as per ASTM D6978.
• Biocompatibility (Sensitization, Irritation, Cytotoxicity, Systemic Toxicity): Laboratory test results demonstrating lack of adverse biological reactions as defined by ISO 10993 standards and evaluated against established pass/fail criteria (e.g., no evidence of sensitization, no irritancy, no mortality/toxicity).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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The Powder Free Nitrile Examination Gloves (Blue) , Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. The tested chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml (10,000 ppm) >240min Doxorubicin HCl 2 mg/ml(2,000 ppm) >240min Etoposide 20 mg/ml (20,000 ppm) >240min Fluorouracil 50mg/ml(50,000 ppm) >240min Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min Ifosfamide 50mg/ml (50,000 ppm) >240min Methotrexate 25mg/ml (25,000 ppm) >240min Mitomycin C 0.5 mg/ml(500 ppm) >240min Mitoxantrone HC1 2 mg/ml (2,000 ppm) >240min Paclitaxel 6 mg/ml (6,000 ppm) >240min Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9) Vincristine Sulfate 1 mg/ml (1,000 ppm) > 240min The tested non-chemotherapy drugs are: Fentanyl Citrate injection 100mcg/2ml >240min Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa

The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are blue color, powder free, nitrile gloves. The gloves are offered in six sizes: XS、S、M、L、XL、XXL, packed in a paper box.

The proposed gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05. The proposed device was modification from the legally marketed (existing) device "Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)"/K202356, manufactured by "KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED", same as the sponsor of this submission.

There are two modifications, one is to add a large model XXL, and the other is to add the "Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" indications for use than the legally marketed (existing) device. Testing has been conducted on the proposed device passed as per ASTM D6978-05, ASTM D6319-19, ASTM D5151-19, ASTMD 6124-06.

The materials and the manufacturing process technology are the same.

The provided document (a 510(k) summary for medical gloves) does not contain information about a study that proves a device meets acceptance criteria related to AI/ML or human reader performance. The document is for "Powder Free Nitrile Examination Gloves" and pertains to mechanical and material properties, as well as resistance to chemical permeation.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size used for a test set or data provenance for an AI/ML device.
3. Number of experts used to establish ground truth or their qualifications for an AI/ML device.
4. Adjudication method for an AI/ML device test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study for human readers with and without AI.
6. Standalone performance of an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
8. Sample size for the training set of an AI/ML device.
9. How the ground truth for an AI/ML training set was established.

However, based on the document, I can present the acceptance criteria and performance for the glove device as non-clinical testing.

Acceptance Criteria and Study for Powder Free Nitrile Examination Gloves

This document describes the non-clinical testing performed on "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing of Gloves):

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

• The document does not specify the exact sample sizes (e.g., number of gloves tested for each attribute) for the physical and chemical resistance tests. It only states that tests were conducted according to the listed ASTM and ISO standards.
• Data Provenance: The testing was conducted to verify that the device meets design specifications and complies with international standards. The origin of the testing data is not explicitly stated beyond being "non-clinical tests."

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

• This is not applicable as the device is a medical glove, not an AI/ML diagnostic or prognostic tool. Ground truth is established by objective physical and chemical measurements following established standards, not by expert consensus or physician reads.

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

• Not applicable for this type of device testing.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used:

• For the physical properties (dimensions, watertightness, tensile strength, powder content), the ground truth is based on direct physical measurement and standard test methods outlined in ASTM standards.
• For chemical permeation (chemotherapy drugs and Fentanyl), the ground truth is established by analytical measurement of breakthrough time according to ASTM D6978-05.
• For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is established by biological assays according to ISO 10993 standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. The "training" for glove manufacturing relates to process control and material specifications, not a data-driven model.

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

• Not applicable as this is not an AI/ML device.

Ask a specific question about this device

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.

The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs" (K240051).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Chemotherapy, Fentanyl Citrate & other drugs Permeation Comparison (Proposed Device K240051):

Warning: Do not use with Carmustine and Thiotepa due to "extremely low permeation times" (29.1 minutes and 78.3 minutes, respectively).

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

• The document primarily refers to standard ASTM and ISO test methodologies for device performance (e.g., ASTM D6319-19, ASTM D6978-05(2019), ISO 10993 series). These standards typically define the sample sizes required for each specific test to ensure statistical validity.
• Data Provenance: The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The tests were performed by Lingshi Hongruida Health Protection Technology Co., Ltd. located in China. The data is retrospective in the sense that the testing was performed and then submitted with the 510(k) application. Specific details on exact sample sizes (e.g., number of gloves tested for each characteristic) within each standard are not explicitly detailed in this summary for every test. However, the chemotherapy drug permeation testing likely involved multiple samples per drug as per ASTM D6978.

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 as the device is a physical medical device (examination glove) and the testing involved objective, quantitative, and standardized measurements according to established consensus standards (ASTM, ISO). There were no "experts" establishing a "ground truth" in the way they would for, say, image interpretation or clinical diagnosis. The ground truth for performance relied on the specified chemical and physical property measurements.

4. Adjudication method for the test set:

• This is not applicable. As mentioned above, the testing involved objective physical and chemical measurements governed by established standards, not subjective interpretations requiring 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 device is an examination glove, not an AI-powered diagnostic tool or imaging software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.

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

• This is not applicable. This device is an examination glove and does not involve any algorithm or AI for standalone performance.

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

• The ground truth for this device's performance is based on objective measurements against established performance standards and chemical permeation resistance thresholds.
  • For physical properties (length, thickness, tensile strength, elongation, watertightness, powder content): The ground truth is the quantitative measurement compared against the specified ASTM standard values.
  • For chemical permeation (chemotherapy drugs, Fentanyl Citrate): The ground truth is the experimentally determined Minimum Breakthrough Detection Time (BDT) in minutes, measured according to ASTM D6978-05(2019).
  • For biocompatibility (irritation, sensitization, cytotoxicity, acute systemic toxicity): The ground truth is the experimental findings and conclusions derived from tests conducted under ISO 10993 series standards.

8. The sample size for the training set:

• This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.

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

• This is not applicable as there is no training set for this type of device.

Ask a specific question about this device

The glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978.

Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).

The provided document describes the acceptance criteria and results of non-clinical testing for "Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate" (K240072). This is a physical medical device (gloves), not an AI/ML powered device. Therefore, questions related to AI/ML specific criteria (such as effect size of human readers with AI assistance, sample size for training sets, number of experts for ground truth, adjudication methods) are not applicable.

Here's the relevant information from the document:

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

Breakthrough Detection Time (BDT) for Chemotherapy Drugs and Fentanyl Citrate:

Please refer to the tables provided in pages 3, 4, 7, and 8 of the document for the detailed BDT for each specific chemotherapy drug and Fentanyl Citrate for both Blue and Purple-Blue gloves. The general acceptance criterion implied is that the gloves provide a certain level of protection (BDT), and the performance reports these measured BDTs. Notably, for Carmustine and Thiotepa, the BDTs are explicitly called out as "extremely low permeation times" with a warning not to use them with these drugs.

2. Sample sized 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 for each specific non-clinical test (e.g., number of gloves tested for physical dimensions, chemotherapy permeation, etc.). However, these tests are generally conducted by manufacturers according to standardized protocols (e.g., ASTM standards) which define the required sample sizes for each test. The provenance specific to the data (e.g., country of origin, retrospective/prospective) is not detailed for these non-clinical bench tests. These are laboratory tests on the product itself.

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. This is a physical device submission (nitrile examination gloves) and not an AI/ML-powered device that would require expert-established ground truth from medical imaging or similar data. The acceptance criteria are based on defined physical and chemical properties measured through standardized bench tests.

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

Not applicable. Adjudication methods are typically associated with human review of data, especially in clinical or AI/ML studies, to establish ground truth. This document pertains to non-clinical bench testing of a physical product.

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 not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device is established through performance against recognized industry standards (e.g., ASTM D6319-19, ASTM D6978-05 (2019), ISO 10993 series). These standards define objective, measurable physical, chemical, and biological properties of the gloves. For example, breakthrough detection time for chemotherapy drugs is a direct measurement based on established laboratory procedures.

8. The sample size for the training set

Not applicable. This is a physical device; there is no "training set" in the context of AI/ML.

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

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

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The Powder-Free Nitrile 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 Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)

The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for "Powder Free Nitrile Examination Gloves." These documents do not contain information related to software or AI-powered medical devices. Therefore, I cannot extract details about acceptance criteria or supporting studies for such a device.

The information you've requested (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically found in documentation for AI/Software as a Medical Device (SaMD) products, reflecting their performance evaluation.

This submission is for a Class I medical device (non-powdered patient examination glove), which is a physical product and does not involve AI or algorithms requiring the type of performance study details you've outlined.

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Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05.

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl

The provided document is a 510(k) clearance letter for "Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl." It primarily outlines the regulatory approval and indications for use, including a table of chemotherapy drugs and their breakthrough detection times.

This document does not contain the kind of information typically found in a study proving an AI/ML device meets acceptance criteria. The requested information (e.g., sample size for test set, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, training set details) is specifically relevant to the evaluation of AI/ML-driven medical devices. The device described here is a physical product (nitrile gloves), not an AI/ML device.

Therefore, I cannot extract the requested information from the provided text.

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Powder-Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder-Free Nitrile Examination Glove

The provided text is a 510(k) summary for a medical device (Powder-Free Nitrile Examination Gloves). It confirms the device's regulatory classification and that it has been deemed substantially equivalent to a predicate device. However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of performance metrics that would typically apply to an AI/ML or diagnostic device.

The regulatory review for these gloves focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through adherence to established standards for examination gloves (e.g., physical properties, barrier integrity, biocompatibility). The document does not describe a performance study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would be relevant to the questions posed.

Therefore, I cannot provide the requested information based on the input text. The questions asked are generally applicable to the validation of AI/ML-based medical devices or diagnostic tools, not to a Class I non-powdered patient examination glove.

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

The subject device is a patient examination glove made from nitrile latex compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.

The provided text is a 510(k) Summary for a medical device: "Powder Free Nitrile Examination Gloves (Black)". This document doesn't describe the kind of acceptance criteria or study that would have the information requested in your prompt (e.g., sample size for training sets, expert qualifications, MRMC studies, effect sizes). The submission is for a Class I general hospital and personal use device, which typically requires a demonstration of substantial equivalence to a predicate device rather than extensive clinical efficacy studies.

Instead, the document focuses on showing that the new device meets established ASTM and ISO standards for examination gloves and is substantially equivalent to another legally marketed glove.

Here's the information that can be extracted relevant to acceptance criteria and performance, as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not applicable or not provided in the document for this type of device and submission):

2. Sample size used for the test set and the data provenance: Not explicitly stated for each test. The tests refer to established standards (e.g., ASTM, ISO), which would define sample sizes within their methodologies. Data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is defined by compliance with established physical and biocompatibility standards, not expert consensus on diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring human adjudication of 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 is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is established by existing, widely recognized industry standards and test methods (ASTM and ISO standards) for physical properties and biocompatibility of examination gloves.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

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