Search Results

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.

Warning: do not use with Carmustine and Thiotepa.

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:

• Carmustine (BCNU) 3.3 mg/ml 21.5 minutes
• Thiotepa 10.0 mg/ml 13.6 minutes

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.

The provided document is an FDA 510(k) clearance letter for a medical device: "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid."

This is a physical medical device (a glove), not a software device or an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML model validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of FDA submission.

The document assesses the device's physical properties and its resistance to permeation by various hazardous substances. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to bench testing against established ASTM and CFR standards for medical gloves.

Here's the breakdown of the relevant information from the document, tailored to the nature of this device:

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

The device (Disposable Powder Free Nitrile Examination Glove, Blue Color) was tested against several physical and chemical permeation standards. The acceptance criteria and results are outlined in the "Assessment of Non-Clinical Performance Data" section (Page 17-19) and the "Indications for Use" section (Page 4-5) and summarized within the "510(k) Summary" (Page 7-11).

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

• Sample Size: The document does not explicitly state numerical sample sizes for each specific test (e.g., how many gloves were tested for a burst, tensile, or permeation). However, it implies that testing was conducted according to the specified ASTM and FDA methodologies, which inherently define minimum sample sizes for material testing (e.g., AQL levels for freedom from holes).
• Data Provenance: The tests are "bench testing" conducted on physical glove samples. The manufacturer is "Ever Global (Vietnam) Enterprise Corporation" from Vietnam, so the testing was likely conducted in accordance with international standards at a facility associated with the manufacturer or a certified testing lab. The data is non-clinical performance data from laboratory experiments, not patient data.

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

• Not Applicable. As this is a physical device subject to material property and permeation testing, "ground truth" is established by adherence to physical measurement standards and chemical analysis protocols (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 for permeation). No human expert interpretation or consensus is required to establish the "truth" of a chemical breakthrough time or tensile strength value.

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

• Not Applicable. Adjudication methods are relevant in subjective human interpretation tasks (e.g., radiology image reading). For objective bench testing of physical properties, results are determined by instrumentation and adherence to standardized protocols, not human 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. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in medical imaging. This is a physical glove, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• The "ground truth" is established through objective, standardized laboratory measurement methods as defined by the referenced ASTM (American Society for Testing and Materials) and CFR (Code of Federal Regulations) standards.
  • For physical properties (Dimensions, Tensile Strength, Elongation, Powder Residual, Freedom from Holes), the ground truth is the measured physical values against the defined thresholds in ASTM D6319-19 and 21 CFR 800.20 & ASTM D5151-19.
  • For chemical permeation (Resistance to Hazardous Drugs), the ground truth is the measured breakthrough time determined by chemical analysis according to ASTM D6978-05.
  • For Biocompatibility, the ground truth is the biological response (cytotoxicity, dermal reactions) as measured per AAMI/ANSI/ISO 10993-5 and 10993-10 standards.

8. The sample size for the training set:

• Not Applicable. This is a physical product, not a machine learning model; therefore, there is no "training set." The product's design and manufacturing process are developed through engineering and material science, not data training.

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

• Not Applicable. As there is no training set for this physical device.

Ask a specific question about this device

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, and xylazine in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.

The provided document is a 510(k) Premarket Notification for a Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine.

This device is a Class I medical device (non-powered patient examination glove). For devices in this class, the FDA typically does not require a clinical performance study with human subjects. Instead, evidence of substantial equivalence to a predicate device is primarily demonstrated through non-clinical performance data (bench testing).

Therefore, the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to this particular device submission. This document describes the performance of a physical examination glove, not an AI or imaging device.

However, I can extract the acceptance criteria and reported device performance from the non-clinical testing:

Acceptance Criteria and Reported Device Performance

The study aims to demonstrate that the subject device (Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine) meets the acceptance criteria for various physical and chemical resistance properties, establishing its substantial equivalence to a predicate device (K193555).

Here is a table summarizing the acceptance criteria and the device's reported performance:

Regarding the specific questions about AI/imaging studies:

• 2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical tests on glove samples.
• 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for physical properties is established by standardized testing methods.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Results are quantitative measurements from lab tests.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is not an AI or imaging device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established through adherence to recognized international/national standards for medical glove testing (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D6978-05, AAMI/ANSI/ISO 10993-5, AAMI/ANSI/ISO 10993-10). These standards define the test methods and performance requirements.
• 8. The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.
• 9. How the ground truth for the training set was established: Not applicable. Manufacturing controls and quality assurance ensure consistency, not a "training set" in the context of AI.

Ask a specific question about this device

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document describes the premarket notification (510(k)) for a medical device: "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate" (K193555). The core of the submission, as it relates to proving the device meets acceptance criteria, focuses on the glove's resistance to permeation by chemotherapy drugs and fentanyl citrate.

Here's an analysis of the provided information to answer your questions:

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

The primary acceptance criteria for the chemotherapy drug and fentanyl citrate resistance are the "Minimum Breakthrough Detection Time (Min.)" as per ASTM D6978-05. The device aims to achieve a breakthrough time of "> 240 minutes" for most listed drugs.

Note on Acceptance Criteria: For most drugs, the stated acceptance criterion is explicitly given as "> 240 minutes" in the "Indications for Use" section and confirmed by the reported performance. For Carmustine and Thiotepa, the document highlights their "extremely low permeation time" and provides their specific breakthrough times. The comparison table (Table 2) then compares these to the predicate, showing the new device's performance. The "Warning: do not use with Carmustine and Thiotepa" statement effectively sets the acceptance criteria for these specific drugs as less than the ideal >240 minutes, acknowledging their known rapid permeation through gloves. The aim for these is to show performance comparable or better than the predicate, which the subject device achieves for Carmustine, but is slightly worse for Thiotepa (Thiotepa: predicate 38.8 min, subject device 23.1 min (short cuff) and 13.6 min (long cuff)). However, since a warning is issued, this outcome appears to be accepted.

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: The document does not explicitly state the specific number of gloves/samples tested for each drug permeation. It refers to testing "in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs," which would define the sample size requirements for the test. However, the exact sample numbers (e.g., how many gloves were tested for each drug) are not provided in this summary.
• Data Provenance: The tests were conducted by Ever Global (Vietnam) Enterprise Corp (Vietnam). The type of study for these tests would be prospective bench testing, as new gloves were manufactured and then tested for their characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a device performance study based on laboratory bench testing, not an AI or diagnostic study involving expert interpretation of medical images. Therefore:

• Number of experts: Not applicable. Ground truth for material properties (like drug permeation) is established through standardized laboratory procedures and measurements.
• Qualifications of experts: Not applicable in the context of human expert review of "ground truth" for clinical data. The "experts" here would be the laboratory personnel qualified to perform ASTM D6978-05 and other relevant material testing standards.

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

Not applicable. This is not a study involving human reader interpretation or adjudication. Device performance is determined by direct physical and chemical testing according to established ASTM standards.

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 510(k) submission for a physical medical device (gloves), not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm. The "standalone performance" is the intrinsic material property of the glove against chemical permeation.

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

The "ground truth" for the device's performance regarding chemotherapy drug and fentanyl permeation is established through direct laboratory measurement using the methodology outlined in ASTM D6978-05. This standard defines how resistance to permeation is assessed, with breakthrough time being the key metric. For other properties like tensile strength, freedom from holes, powder residual, and biocompatibility, the ground truth is also established by specific ASTM standards and biological evaluation guidelines (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. This is a traditional device submission, not an AI/machine learning product that requires a "training set." The gloves are manufactured, and then samples from the manufacturing batches are subjected to testing (the "test set" in this context).

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

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

Ask a specific question about this device

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile compound. non-sterile (as per 21 CFR 880.6250. Class I). The patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document is a 510(k) Premarket Notification from the FDA, evaluating a medical device for substantial equivalence to a legally marketed predicate device. The information provided heavily focuses on bench testing and comparison to standards, rather than clinical studies with human participants or AI-driven performance metrics typically found in software as a medical device (SaMD) clearances.

Therefore, many of the requested details, such as the use of a test set with ground truth established by experts, MRMC studies, or training set details for an AI model, are not applicable to this document. The "device" in this context is a physical product (nitrile examination gloves) and not an AI/ML software.

The acceptance criteria and performance are related to the physical and chemical properties of the gloves, not AI performance.

Here's an attempt to answer the questions based only on the provided text, noting where information is not applicable (N/A) or not present.

Acceptance Criteria and Device Performance for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established by adherence to various ASTM standards and 21 CFR regulations for physical and chemical properties, and specifically ASTM D6978-05 for chemotherapy drug permeation. The reported performance is the device's measured characteristics against these standards.

Note: For Carmustine and Thiotepa, the "acceptance criteria" is not explicitly defined as a threshold, but rather it is noted that these drugs have "extremely low permeation time," and the observed times are reported. The comparison is against the predicate device's performance for these specific drugs, which the proposed device improved upon (59.4 vs 12.4 for Carmustine, 118.5 vs 24.4 for Thiotepa).

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: The document does not specify the exact sample sizes for each specific test (e.g., how many gloves were tested for pinholes, or how many samples for each chemotherapy drug). It references adherence to ASTM standards, which would dictate appropriate sample sizes for these types of bench tests.
• Data Provenance: The tests were conducted to evaluate the qualities of the "Disposable Powder Free Nitrile Examination Glove, Blue Color" manufactured by Ever Growth (Vietnam) Co. Ltd. (Vietnam). These are bench tests on manufactured products, not data from human subjects or collected retrospectively/prospectively in a clinical setting.

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

• N/A. The "ground truth" for the performance of these gloves is established by objective, standardized bench testing methods (e.g., ASTM standards for material properties, chemical permeation tests). There is no "expert consensus" or human adjudication involved in determining these physical and chemical properties.

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

• N/A. No adjudication method is applicable as these are objective bench test measurements, not subjective human interpretations that require reconciliation.

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. This device is a physical medical glove, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant.

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

• N/A. This device is a physical medical glove. "Standalone performance" in the context of an algorithm is not applicable.

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

• The "ground truth" for the device's performance is determined by objective measurements obtained through standardized bench testing methods (e.g., ASTM International standards for physical properties, chemical permeation analysis). For example, a "pinhole" is objectively detected using a water leak test, and "tensile strength" is measured mechanically.

8. The sample size for the training set

• N/A. This is a physical device, not an AI/ML model for which a "training set" would be used.

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

• N/A. Not applicable, as there is no training set for a physical product.

Ask a specific question about this device