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A Nittile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient. This glove has also been tested for use with Chemotherapy Drugs.

Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs

This document is a 510(k) premarket notification for a medical device: "Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs".

The main acceptance criteria for this device, beyond its primary function as an examination glove, is its resistance to permeation by various chemotherapy drugs. This is evaluated by the "Minimum Breakthrough Detection Time (minutes)" for each tested drug.

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

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

Note: The document itself specifies a warning based on these results: "WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA" due to their extremely low permeation times (15.0 minutes and 30.1 minutes respectively). While the provided table states the reported performance, the implied acceptance criteria for safe use would be a breakthrough time considered acceptable for handling (likely much higher than 15 or 30 minutes, commonly 240 minutes per ASTM D6978). The device meets the criteria by reporting its performance, allowing users to make informed decisions and the FDA to determine substantial equivalence.

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 size for the test set (number of gloves tested or repetitions per drug). It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. We only know the applicant is YTY Industry (Manjung) Sdn Bhd from Malaysia.

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 device is a physical product (nitrile examination glove) and not an AI or diagnostic tool requiring expert interpretation of images or data. Therefore, the concept of "experts establishing ground truth" in the typical sense for test sets of AI models is not applicable here. The ground truth (breakthrough time) is established through standardized laboratory testing protocols (likely ASTM D6978 for chemotherapy drug permeation), not human expert consensus.

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

Not applicable for a physical product performance test. This concept is relevant for studies involving human interpretation or subjective assessment where consensus among multiple reviewers is needed to establish ground truth.

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 physical product (glove), not an AI or assistive diagnostic technology.

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

Not applicable. This device is a physical product (glove), not an algorithm or software.

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

The ground truth for the chemotherapy drug permeation is established through laboratory testing using standardized methods, likely following a standard like ASTM D6978 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs". This involves precise measurement of the time it takes for a detectable amount of a chemotherapy drug to pass through the glove material.

8. The sample size for the training set

Not applicable. This device is a physical product. The concept of a "training set" is relevant for machine learning models, not for traditional manufacturing and testing of physical goods.

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

Not applicable, as there is no "training set" in the context of this device.

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A patient examination glove is a disposable device intended for medical purpose 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 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

Aloe Vera: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, and Vincristine Sulfate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.

Non-Sterile, Powder Free Nitrile Examination Gloves: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, Vincristine Sulfate, and Fentanyl Citrate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.

Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs and Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate.

The provided text is related to a 510(k) premarket notification for nitrile examination gloves and does not contain information about the acceptance criteria or a study that typically involves AI/ML device performance. Instead, it details the indications for use and the gloves' resistance to permeation by chemotherapy drugs and fentanyl citrate, in accordance with ASTM D6978.

Therefore, I cannot extract the information required to answer your questions as they pertain to AI/ML device performance studies and acceptance criteria. The document focuses on regulatory clearance for medical gloves based on chemical resistance testing, not on an AI/ML algorithm's performance.

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A patient examination glove is a disposable device intended for medical purpose 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 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes

WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA

A patient examination glove is a disposable device intended for medical purpose 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 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate:

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 30.3 minutes ThioTEPA (10.0 mg/ml): 91.0 minutes

CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS

Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue; Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue

This document describes two types of non-sterile, powder-free nitrile examination gloves:

1. Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue
2. Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue

The acceptance criteria for both devices are primarily based on their resistance to permeation by chemotherapy drugs, as tested according to ASTM D6978 Standard Practice. For the second device, resistance to Fentanyl Citrate is also included.

The study proving the device meets the acceptance criteria is detailed in the "Indications for Use" sections for each glove type.

1. Table of Acceptance Criteria and Reported Device Performance

Device 1: Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue

Note: The document explicitly warns: "WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA" due to their extremely low permeation times (11.3 minutes and 7.4 minutes, respectively). This implicitly sets an acceptance criterion that usage with these drugs is not recommended, rather than a performance threshold for them. For other drugs, a permeation time of "> 240 minutes" appears to be the target performance for safe use.

Device 2: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue

Note: The document states: "CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS". Similar to Device 1, this indicates that while tested, their permeation times (30.3 minutes and 91.0 minutes, respectively) are lower than the target for other drugs, suggesting a cautionary use or implicit lower acceptance for these specific substances.

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

The document specifies that the gloves were "tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

• Sample Size for the Test Set: The document does not explicitly state the sample size (e.g., number of gloves or tests performed per drug) used for these tests. The ASTM D6978 standard would likely specify the required number of replicates.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. The testing was conducted by YTY Industry (Manjung) Sdn Bhd, located in Malaysia, suggesting the tests were performed in Malaysia. The nature of laboratory testing like this is inherently prospective for the specific batch or design of gloves being evaluated.

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

This question is not applicable in the context of this document. The "ground truth" here is the physical measurement of chemical permeation, determined by laboratory testing methods described in ASTM D6978, rather than expert interpretation of medical images or diagnostic data. There is no indication of experts being used to establish a ground truth for the test results.

4. Adjudication method for the test set

This question is not applicable. The test results are objective chemical permeation measurements (breakthrough detection time), not subjective interpretations that require 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 question is not applicable. The device is a medical glove, not an AI-powered diagnostic tool requiring human interpretation or MRMC studies.

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

This question is not applicable. The device is a medical glove, not an algorithm. The performance described is that of the physical product itself.

7. The type of ground truth used

The ground truth used is laboratory measurement of chemical permeation according to the ASTM D6978 standard. This standard describes methods to evaluate the resistance of medical gloves to permeation by chemotherapy drugs, typically by detecting the breakthrough of a specific chemical through the glove material over time.

8. The sample size for the training set

This question is not applicable. The device consists of physical gloves, not a machine learning model, and therefore does not have a "training set" in the computational sense. The manufacturing process of gloves might involve quality control and material testing, but this is distinct from training a dataset for an algorithm.

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

This question is not applicable, as there is no "training set" for this physical device.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non-Sterile, PF Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs - Blue

The provided document is a 510(k) clearance letter from the FDA for "Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs - Blue." This document does not describe an AI/ML powered device, but rather a standard medical device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for an AI device is not applicable to this document.

The document does include a table indicating the performance of the gloves with various chemotherapy drugs, specifically the "Average Breakthrough Detection Time." This table could be interpreted as describing device performance against acceptance criteria for chemotherapy drug permeation, but it is not related to AI/ML performance.

Acceptance Criteria and Reported Device Performance (as related to chemotherapy drug permeation for the gloves):

The document states that "Carmustine (3.3 mg/ml): 11.3 minutes" and "ThioTEPA (10.0 mg/ml): 7.4 minutes" have "extremely low permeation time," which implies that for these drugs, the gloves do not offer extended protection. This information would be crucial for users to understand the limitations of the device.

All other requested information about an AI/ML study is not present in this document as it is not a submission for an AI/ML medical device.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided text describes the acceptance criteria and performance data for two types of nitrile examination gloves: "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)" and "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Cobalt Blue)". The information is presented as a 510(k) summary, comparing the subject devices to a predicate device (K161215).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the gloves are primarily based on ASTM standards (ASTM D6319-10 for physical and dimensional properties, ASTM D6124-06 for powder-free claims, and ASTM D6978-05 for chemotherapy drug permeation), as well as ISO 10993-10 for biocompatibility. The reported device performance is compared against these standards and the predicate device.

Warning Statements related to acceptance/use:

• Blue Glove: "WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 15.0 minutes and ThioTepa: 30.1 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA."
• Cobalt Blue Glove: "WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 2.4 minutes and ThioTepa: 1.9 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA."

Study Proving Device Meets Acceptance Criteria:

The device's performance is demonstrated through testing against recognized standards. The document is a 510(k) summary for premarket notification, which means the manufacturer conducted tests to show substantial equivalence to a legally marketed predicate device.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for permeation, water tightness, or biocompatibility). The testing is generally indicated as "Meets" specific ASTM/ISO standards, which typically prescribe minimum sample sizes for conformity testing.
• Data Provenance: The tests were conducted to support a premarket notification for devices manufactured by YTY Industry (Manjung) Sdn Bhd in Malaysia. This suggests the data originates from tests conducted by or for the manufacturer, likely in an accredited lab to demonstrate compliance with the referenced international standards. The data is retrospective in the context of this 510(k) submission, meaning the tests were performed prior to the submission to demonstrate device characteristics.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance testing (e.g., permeation time, physical properties) is established through standardized laboratory methods and instrument readings, not expert consensus or interpretation of images.

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

This is not applicable as the determination of device characteristics (e.g., breakthrough time, physical dimensions) is based on objective measurements and standardized test protocols, not on human expert 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 document describes performance testing for medical gloves, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This is not applicable as the device is a medical glove, not an algorithm.

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

The "ground truth" for the performance claims of these gloves is based on:

• Standardized Test Methods: Adherence to established international standards like ASTM D6319-10, ASTM D6978-05, ASTM D6124-06, and ISO 10993-10.
• Objective Measurements: Laboratory measurements of physical properties (e.g., dimensions, thickness, water leakage, powder content) and chemical permeation breakthrough times using specified equipment and protocols.

8. The sample size for the training set:

This is not applicable. The device is a manufactured good (gloves), not an AI model requiring a training set.

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

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

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