Search Results

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose 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 and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19. Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.

This document is a 510(k) Premarket Notification from the FDA for medical gloves, specifically "Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)". It details the device's technical characteristics, indications for use, and a comparison to a predicate device, along with non-clinical testing results to demonstrate substantial equivalence.

Here's an analysis based on your request, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria and performance data are primarily described in the "NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA" and "BIOCOMPATIBILITY DATA" sections (pages 9-12).

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

The document does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for permeation, dimensions, etc.) beyond what's implied by the AQL 2.5 for freedom from holes (which dictates the sampling plan based on lot size, but the lot size isn't provided).

• Data Provenance: The studies were non-clinical bench tests and biocompatibility tests performed to established ASTM and ISO standards. The location where these tests were conducted is not specified in this FDA letter, but typically these are performed in certified laboratories. The data is prospective, in the sense that the tests were conducted specifically to demonstrate the performance of the device for this submission.

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

This document describes a 510(k) submission for an examination glove, which is a Class I medical device. The "ground truth" for these tests are established by widely accepted international and national standards (ASTM and ISO). These standards themselves are developed by committees of experts in relevant fields (materials science, chemistry, toxicology, medical device manufacturing, etc.), and the laboratories performing the tests follow strict protocols defined by these standards.

The document does not mention the use of individual human experts (like radiologists for imaging studies) to establish "ground truth" for the performance or safety of the glove itself in the way that would apply to, for example, an AI diagnostic aid. The "ground truth" for the glove's performance is derived directly from the application of the specified physical, chemical, and biological test methods.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and testing. Adjudication methods (like 2+1, 3+1 consensus) are relevant for subjective expert review processes, such as interpreting medical images or clinical outcomes. For the physical and chemical property tests of a glove, the results are quantitative measurements or pass/fail criteria against a defined standard, not subject to human interpretation discrepancies requiring adjudication.

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

No. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) perform tasks with and without AI assistance to measure the AI's impact on human performance. This document pertains to a physical medical device (examination glove), not an AI diagnostic system.

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

Not applicable. This device is a glove, not an algorithm. The performance tests are "standalone" in the sense that they measure the intrinsic properties of the glove itself.

7. The Type of Ground Truth Used

The ground truth for this device is based on defined physical, chemical, and biological performance standards and test methodologies (e.g., ASTM D6319-19 for glove properties, ASTM D6978-05 for chemical permeation resistance, ISO 10993 series for biocompatibility). These standards specify the methods for measuring parameters like tensile strength, freedom from holes, chemical breakthrough time, and biological responses (irritation, sensitization, cytotoxicity, systemic toxicity).

8. The Sample Size for the Training Set

Not applicable. This document is about a physical medical device (glove), not a machine learning or AI model. Therefore, there is no "training set."

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

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

Ask a specific question about this device

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purpose 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 in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

Bleomycin Sulfate (15.0 mg/ml)
Busulfan (6.0 mg/ml)
Carboplatin (10.0 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0 mg/ml)
Cytarabine (100.0 mg/ml)
Dacarbazine (10.0 mg/ml)
Daunorubicin HCl (5.0 mg/ml)
Docetaxel (10.0 mg/ml)
Doxorubicin HCl (2.0 mg/ml)
Epirubicin HCl (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fludarabine (25.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Gemcitabine (38.0 mg/ml)
Idarubicin HCl (1.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Irinotecan (20.0 mg/ml)
Mechlorethamine HCl (1.0 mg/ml)
Melphalan (5.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCl (2.0 mg/ml)
Paclitaxel (6.0 mg/ml)
Rituximab (10.0 mg/ml)
Trisenox (1.0 mg/ml)
Vincristine Sulfate (1.0 mg/ml)

The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes

Warning: Not for Use with: Carmustine, Thiotepa

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) with sizes Medium, Large, X-Large and XX-Large are included in the submission.

The provided text describes the acceptance criteria and performance of the Nephron Nitrile Powder-Free Nitrile Examination Gloves.

Here's the requested information:

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

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 sizes for each test in the level of detail (e.g., number of gloves tested for each specific property or chemotherapy drug). It only refers to compliance with the standards (e.g., AQL 2.5 for freedom from holes).

The data provenance (country of origin, retrospective/prospective) is not mentioned. These are bench tests, not human trials or medical imaging data.

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 information is not applicable. The document describes bench testing of physical and chemical properties of gloves, not expert interpretation of medical images or clinical data.

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

This information is not applicable. The tests are laboratory-based and follow standardized testing protocols, which do not typically involve adjudication methods like those used for expert review of clinical cases.

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 information is not applicable. The document describes the testing of medical examination gloves, which are physical products, not AI systems or medical imaging devices. Therefore, MRMC studies and AI assistance are irrelevant.

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

This information is not applicable. The document describes the testing of medical examination gloves, which are physical products, not algorithms.

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

The "ground truth" for these tests is defined by the technical specifications and performance requirements outlined in the referenced ASTM and ISO standards. For example:

• Physical properties (length, width, thickness, tensile strength, elongation) are measured objectively against defined numerical limits.
• Freedom from holes is assessed against an Acceptable Quality Limit (AQL), a statistical measure.
• Resistance to chemotherapy drugs is measured by detecting breakthrough time using specific analytical methods defined in ASTM D6978.
• Biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity) are assessed by observing biological responses in animal models or in vitro systems against established criteria for non-irritancy, non-sensitization, and non-toxicity according to ISO standards.

Essentially, the "ground truth" reflects compliance with regulatory and industry standards for glove performance and safety.

8. The sample size for the training set

This information is not applicable, as this is not a machine learning model.

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

This information is not applicable, as this is not a machine learning model.

Ask a specific question about this device