Search Results

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) meets all the requirements of ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.

This document is a 510(k) premarket notification for Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black). It describes the device and compares it to a predicate device (Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green), K180476).

Since this document is for a medical glove, not an AI/ML powered medical device, the information requested in the prompt related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable. The device's performance is demonstrated through non-clinical testing against recognized standards.

Here's a breakdown of the acceptance criteria and performance as gathered from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device, "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)," meets established standards for medical examination gloves. The key acceptance criteria and reported performance, especially concerning chemotherapy drug permeation, are detailed below. The comparison is made against the predicate device (K180476) and relevant ASTM/ISO standards.

Study Information for the Device:

As mentioned, much of the requested information is for AI/ML devices and is not applicable to a physical medical device like examination gloves. The provided document is a 510(k) submission, confirming substantial equivalence to a predicate device based on non-clinical performance testing.

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

• Sample Size for Test Set: Not explicitly stated but implied to be sufficient for compliance with the referenced ASTM and ISO standards for glove testing (e.g., ASTM D6978 for chemotherapy permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility). These standards define sampling plans for lot release testing. For instance, ISO 2859 for "Sampling Procedures and Tables for Inspection by Attributes" is referenced, indicating a statistical sampling approach.
• Data Provenance: The manufacturing company is Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The testing would presumably have been conducted in laboratories, potentially in Malaysia or certified testing facilities elsewhere, in accordance with the specified international standards. The data is prospective in the sense that the tests were conducted specifically for 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. The "ground truth" for a medical glove is determined by its physical and chemical properties as measured against established performance standards, not by expert interpretation of data. Laboratory testing provides the objective "ground truth."

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

• Not applicable. Adjudication methods are relevant for subjective interpretations, typically in clinical readings or image analysis for AI/ML. For glove testing, objective measurements are taken according to standard protocols.

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 physical medical device, not an AI-powered diagnostic tool.

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

• Not applicable. This is a physical medical device.

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

• The "ground truth" is established through objective laboratory testing results against predetermined pass/fail criteria defined by international standards (ASTM, ISO). These tests measure properties such as physical dimensions, tensile strength, elongation, powder content, integrity (watertightness), chemotherapy drug permeation time, skin irritation, sensitization, and cytotoxicity.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.

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

• Not applicable. There is no training set for this type of device.

Ask a specific question about this device

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:

Please note that the following drugs have extremely low permeation time for
*Carmustine (BCNU) 3.3mg.ml - 23.4 (mins)
*Thiotepa 10.0 mg/ml - 16.2 (mins)

The proposed device is the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green). The proposed device is for single use and is provided non-sterile. The device meets the requirements for dimensions, physical properties, and thickness in ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application. The device accomplishes its intended function by creating a physical barrier between the examiner and patient and creates a barrier for the chemotherapy drugs listed in the Indications for Use.

This document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves tested for use with chemotherapy drugs. It focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Here's the information extracted and organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the chemotherapy drug permeation test appears to be established by comparison to the predicate devices. For most drugs, the criterion is a minimum breakthrough detection time of ">240 minutes". For Carmustine and Thiotepa, the low permeation times observed for both the new device and the predicate lead to a warning statement, indicating that these drugs have "extremely low permeation times" and are not held to the ">240 minutes" criterion.

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

• The document does not explicitly state the sample size used for the test set for properties like chemotherapy drug permeation, physical properties, or biocompatibility. It only reports "meets" or specific breakthrough times, implying that tests were conducted according to relevant standards (e.g., ASTM D6978-05 for chemotherapy drug permeation and ASTM D6319-10(2015) for physical properties and dimensions). These standards typically define sampling plans.
• Data Provenance: The manufacturer is Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The document does not specify if the testing was performed in Malaysia or another country. The data is non-clinical performance data, likely from prospective testing conducted to support the 510(k) submission.

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 medical glove, and its performance is evaluated through objective, standardized laboratory tests against established physical, chemical, and biological criteria, not through expert interpretation of images or patient data to establish a ground truth.

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

• This is not applicable. The evaluation of medical gloves against performance standards (e.g., ASTM, ISO) involves quantitative measurements and predefined pass/fail criteria, not subjective interpretation requiring adjudication by experts.

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. The device is a physical medical glove, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.

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

• This is not applicable. The device is a physical medical glove and does not involve any algorithm or AI component.

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

• The "ground truth" for this device is based on objective, standardized test methods and criteria defined by international and national standards (e.g., ASTM D6319, ASTM D6124, ASTM D6978, ISO 10993, 21 CFR 800.20). These standards establish the acceptable performance characteristics for medical gloves. For biocompatibility, it's based on "passes" criteria of ISO standards. For chemotherapy permeation, it's the objectively measured breakthrough detection time.

8. The sample size for the training set:

• This is not applicable. The device is a physical medical glove and does not utilize a "training set" in the context of machine learning or AI. Its design and manufacturing are based on engineering principles and material science, not data-driven model training.

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

• This is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.

The proposed devices are Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim. The gloves are available in two colors: blue and white. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White)" and "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue)". This document is for a medical device (gloves) and not for an AI/ML-driven medical device or software. Therefore, the questions related to AI/ML device testing (such as sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to the content provided.

However, I can extract the acceptance criteria and the study results for the glove's performance as presented in the document, especially regarding its resistance to chemotherapy drugs and other physical properties.

Here's the information based on the provided document, addressing the relevant points and indicating "N/A" for those that do not apply to this type of device:

Device Description: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the gloves are primarily based on ASTM standards and comparisons to a predicate device (K141982). The key performance characteristic tested for this submission is the "Breakthrough Detection Time" for various chemotherapy drugs, which reflects the glove's ability to protect against exposure.

Acceptance Criteria & Device Performance Comparison (Current Device vs. Standards/Predicate)

Note: For Carmustine and Thiotepa, while the breakthrough times might seem low, the predicate also had low times (Thiotepa as low as 2 minutes). The current device shows improved or comparable performance for these challenging drugs, and the critical acceptance criterion is that the warning statement regarding these drugs' properties is present and updated to reflect the tested performance.

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

The document does not specify the exact sample size for each specific test (e.g., number of gloves tested for chemotherapy permeation or physical properties). However, the testing would have been conducted in accordance with the cited ASTM standards, which define the necessary sample sizes and testing methodologies for such evaluations.

• Data Provenance: The device is manufactured by Comfort Rubber Gloves Industries Sdn Bhd in Matang, Perak, Malaysia. The testing data would originate from laboratory tests conducted on the manufactured gloves.
• Retrospective or Prospective: These tests are prospective (pre-market) evaluations conducted specifically to support the 510(k) submission.

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

N/A. This is a physical device where "ground truth" is established through standardized laboratory testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility) that yield objective measurements, rather than expert interpretation of complex data (like medical images).

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

N/A. Not applicable for physical device performance 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

N/A. Not applicable for this physical device.

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

N/A. Not applicable for this physical device.

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

The "ground truth" for this device is based on objective measurements derived from standardized laboratory test methods (e.g., ASTM standards for glove performance and ISO standards for biocompatibility). For instance, the breakthrough detection time for chemotherapy drugs is a direct measurement based on chemical analysis, not expert consensus or clinical outcomes.

8. The sample size for the training set

N/A. This document pertains to a physical medical device (gloves), not an AI/ML system requiring a training set.

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

N/A. This document pertains to a physical medical device (gloves), not an AI/ML system.

Ask a specific question about this device

A powder free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml: 1.0 minute Thiotepa, 10.0mg/ml: 31.3 minutes

These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.

This document does not describe a device that uses Artificial Intelligence (AI) or Machine Learning (ML). It is an FDA 510(k) premarket notification for Powder Free Nitrile Examination Gloves Tested For Use with Chemotherapy Drugs.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML device is not applicable to this document.

The document focuses on the physical and chemical properties of the gloves, primarily their resistance to permeation by chemotherapy drugs, and compares them to established ASTM standards and a predicate device.

However, to address the acceptance criteria and performance data as presented in the document for the physical device (gloves):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the gloves are primarily based on ASTM standards. The relevant performance data is provided in "Table 1" on page 4 of the document, comparing the applicant's device to a predicate device and relevant standards.

Note on Chemotherapy Drug Permeation: The "acceptance criteria" here are comparison points from the predicate device and the standard. The device performance for Carmustine and Thiotepa for the current device are lower than >240 minutes, but still considered acceptable with explicit warnings regarding their low permeation times, similar to how the predicate device also had drugs with low permeation times. For Thiotepa, the current device performance (31.3 minutes) is significantly better than the predicate (2.0 minutes). For Carmustine, the current device performance (1.0 minute) is lower than the predicate (15.0 minutes). These differences are noted and addressed by a warning statement.

This summary is based on the information provided, which details the device's compliance with established industry standards for patient examination gloves and specific testing for chemotherapy drug permeation.

Ask a specific question about this device

A powder free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

Not Found

This document describes a 510(k) premarket notification for "Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Non-Sterile)". The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices for general patient examination glove use, and additionally, to provide data on the gloves' resistance to permeation by chemotherapy drugs.

As such, the information provided focuses on the testing for chemotherapy drug permeation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the test standard ASTM D6978-05, which is a standard practice for assessing medical gloves for permeation by chemotherapy drugs. While the document doesn't explicitly state a "pass/fail" threshold for breakthrough time (e.g., all drugs must be > X minutes), it does highlight drugs with permeation times less than 240 minutes, implying that longer breakthrough times are generally more desirable. The reported performance is the minimum breakthrough detection time for each drug.

Note on Acceptance Criteria: The document explicitly notes: "Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)". This indicates that while the device was tested, a breakthrough time of less than 240 minutes for these specific drugs is acknowledged and disclosed, rather than being an outright "failure". The acceptance criterion is therefore the performance according to the specified ASTM standard, with the understanding that users would be informed about the permeation characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size (number of gloves or individual tests) used for the chemotherapy drug permeation testing. It only lists the results for each drug.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective". However, the manufacturer is Maxter Glove Manufacturing Sdn. Bhd. in Malaysia, suggesting the testing likely occurred in or was commissioned by the manufacturer, possibly in Malaysia or a testing lab accredited to perform ASTM D6978-05. The testing itself is a prospective performance test of the device.

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

This type of device (patient examination gloves) and the specific test (chemotherapy drug permeation) do not involve "experts" establishing a ground truth in the traditional sense of clinical diagnosis or interpretation. The "ground truth" is established by the standardized laboratory test procedure itself (ASTM D6978-05), which objectively measures the breakthrough time of the chemotherapy drugs through the glove material. The "truth" is the measured time according to the standard.

4. Adjudication Method for the Test Set

Not applicable. This is a laboratory performance test, not a subjective assessment requiring adjudication. The results are quantitative measurements.

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 performance test for a patient examination glove, not an AI-assisted diagnostic or interpretive device involving human readers.

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

Not applicable. This is a physical device (glove), not an algorithm or AI. The testing performed is an objective measurement of its physical properties.

7. The type of ground truth used

The ground truth used is objective laboratory measurement based on a standardized test method (ASTM D6978-05). This standard details how to measure the permeation of chemotherapy drugs through medical glove materials, providing a quantifiable breakthrough time.

8. The sample size for the training set

Not applicable. This is a physical device undergoing performance testing, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning model, there is no training set or associated ground truth for a training set.

Ask a specific question about this device

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Pink, Black, Grey, and Blue Peppermint Scented)

This document is a 510(k) clearance letter from the FDA for "Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs." It does not contain information on acceptance criteria for a device's performance 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

Ask a specific question about this device

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy (Blue)

This document is a 510(k) premarket notification approval letter for "Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy (Blue)". It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device.

Therefore, I cannot answer the question based on the provided text. The document is about medical gloves, not an AI/ML device, and thus doesn't discuss performance metrics like sensitivity, specificity, or typical study designs for AI systems.

Ask a specific question about this device