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 non-powdered 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.

A Disposable Powder Free Vinyl Examination Gloves (with color Beige or Clear) is a patient examination glove made from poly (vinvl chloride), non-sterile (as per 21 CFR 880.6250, Class I). The operation principle of this medical device is 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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

The document provides information about the non-clinical performance evaluation of "Disposable Powder Free Vinyl Examination Gloves, Beige/Clear" to demonstrate its substantial equivalence to a predicate device.

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

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

Ask a specific question about this device

A non-powdered 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.

A Disposable Powder Free Vinyl Exam Glove (with color Black, Blue, or Purple) is a patient examination glove made from poly (vinyl chloride), non-sterile (as per 21 CFR 880.6250, Class I). This device is available in size S, M, L, and XL. The operation principle of this medical device is 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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

The provided text describes the acceptance criteria and the results of non-clinical performance testing for a medical device, specifically Disposable Powder Free Vinyl Exam Gloves.

Here's a breakdown of the requested information:

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

• Palm - 0.08 mm min.
• Finger - 0.08 mm min.
  Palm Width:
• Small 85 ± 5 mm
• Medium 95 ± 5 mm
• Large 105 ± 5 mm
• X Large 115 ± 5 mm | Pass |
  | Freedom from holes (Water leak) | G-I/AQL 2.5 | Pass |
  | Tensile strength | Before Aging: 11 MPa, min.
  After Aging: 11 MPa, min. | Pass |
  | Elongation | Before Aging: 300% min.
  After Aging: 300% min. | Pass |
  | Powder Residual |

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, White/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 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.

The provided text is a 510(k) summary for Disposable Powder Free Nitrile Examination Gloves, white and blue colors, tested for use with chemotherapy drugs. It focuses on the safety and effectiveness of the device through non-clinical testing and comparison to a predicate device.

Here's an analysis to extract the requested information, noting that much of it pertains to AI/software device studies and is not applicable to this type of medical glove submission:

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

Ask a specific question about this device