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A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient or victim. This specialty glove has also been tested for use with the Opioid drugs Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid.

Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

This document describes the regulatory clearance of a medical device, specifically a type of examination glove, by the FDA. It does not contain information about an AI-powered diagnostic device or a study proving its performance against acceptance criteria in the context of AI/medical imaging, as is implied by the questions asking about MRMC studies, training/test sets, and expert consensus.

Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) clearance letter for a physical product (gloves) that has been tested for resistance to certain opioids, not an AI or algorithm-driven device.

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A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient or victim. This specialty glove has also been tested for use with the Opioid drugs Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid.

Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free. Non-sterile. Ambidextrous. Beaded Cuff. Medical Grade Exam Gloves. Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

This document describes a 510(k) premarket notification for "Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves," which have been "Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)."

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for these gloves are defined by their resistance to permeation by specific opioid drugs. The performance is reported as the minimum breakthrough time.

• Heroin | (100mcg/2mL)
• (saturated solution) | >240 minutes | >240 minutes |
  | Fentanyl citrate (injectable)
• Heroin in Simulated Gastric
  Acid Mix | (100mcg/2mL)
  Saturated Solution into
  simulated Gastric Acid | >240 minutes | >240 minutes |

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the specific sample size (e.g., number of gloves tested) or the provenance (country of origin, retrospective/prospective) of the data for these permeation tests. The information is presented as a summary of the test results rather than a detailed study protocol.

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

This information is not applicable to the type of device and study being described. The "ground truth" here is established by standardized chemical permeation testing, not by expert interpretation of medical images or clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. This is a material permeation test.

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

No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of AI assistance on human reader performance, which is not relevant for testing the chemical resistance of medical gloves.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This concept is not directly applicable. The "device" in question is a physical glove, not an algorithm. The performance described is inherent to the material properties of the glove itself, measured through chemical testing, which is analogous to a "standalone" performance if we think of the glove's material as the "system" being evaluated. No human interpretation is involved in determining the breakthrough time.

7. The Type of Ground Truth Used

The ground truth used is standardized laboratory chemical permeation testing data. This involves precise measurements of the time it takes for specific concentrations of opioid substances to permeate the glove material under controlled conditions, as opposed to expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. These are medical exam gloves, not an AI or machine learning device requiring a training set.

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

This information is not applicable for the same reason as above; there is no training set for a physical exam glove. The performance criteria are based on established standards for chemical resistance in protective materials.

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The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

Powdered Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.

This document describes the acceptance criteria and performance of the NitriTech® Non-Sterile Powdered Nitrile Examination Glove, as presented in the 510(k) summary K093516. It details the tests conducted to demonstrate substantial equivalence to a predicate device and adherence to relevant ASTM standards.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria and Performance:

• For the "Length" and "Palm Width" tests, the reported performance is a range or a minimum value, which falls within or exceeds the specified ASTM criteria.
• For "Thickness (Finger)", the reported minimum performance (0.06mm) exceeds the ASTM minimum (0.05mm).
• For "Thickness (Palm)", the reported minimum performance (0.05mm) meets the ASTM minimum (0.05mm).
• For "Tensile Strength" (Before and After Aging), the reported range (18-33 Mpa) exceeds the ASTM minimum (14 Mpa).
• For "Ultimate Elongation" (Before Aging), the reported range (500-630%) meets or exceeds the ASTM minimum (500%).
• For "Ultimate Elongation" (After Aging), the reported range (500-610%) significantly exceeds the ASTM minimum (400%).
• "Powder Content" had no specific maximum stated in ASTM D6319-00a, but the device reports a maximum of 120mg/glove.
• For "Primary Skin Irritation" and "Dermal Sensitization", the reported scores are well below the thresholds indicating irritation or hypersensitivity, thus meeting the biocompatibility requirements.

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

The exact sample sizes for each specific test (e.g., number of gloves tested for holes, length, etc.) are not explicitly stated in the provided 510(k) summary. The summary refers to "Third Party test data is available in Appendix A" and "Ammendment E", which would contain these specifics.

Data Provenance: The tests were conducted by a "Third Party" and "Mediamal Testing and Consultancy Services" for biocompatibility. The country of origin of this data is not specified within the provided text. The data is retrospective in the sense that the tests were performed on finished product samples prior to the 510(k) submission.

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

This section is not applicable as the device is a physical examination glove. The "ground truth" for its performance is established through standardized physical, chemical, and biological testing methods (ASTM, CPSC, ISO standards), not through expert consensus on interpretation. Therefore, no experts in a clinical interpretation sense were used to establish ground truth for this device performance data.

4. Adjudication Method for the Test Set

This is not applicable for the type of testing performed on an examination glove. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or imaging interpretation where there is subjective assessment that requires consensus. The performance tests for the glove are objective measurements (e.g., length, thickness, tensile strength, hole detection) or standardized biological assays with clear pass/fail criteria.

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 an examination glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This is not applicable. The device is an examination glove, not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established industry standards and objective measurements. Specifically:

• ASTM D6319-00a: Standard Specification for Nitrile Examination Gloves for Medical Application, which defines acceptable ranges and methods for physical properties (dimensions, thickness, tensile strength, elongation) and hole detection.
• ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (used for tensile properties unaged).
• ASTM D573: Standard Test Method for Rubber—Deterioration in an Air Oven (used for tensile properties aged).
• ASTM D6124-06 Section 7 Procedure II: Standard Test Method for Residual Powder on Medical Gloves.
• CPSC Title 16 Chapter II Part 1500: Regulations for the Federal Hazardous Substances Act, specifically for Primary Skin Irritation.
• ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

These standards define the pass/fail criteria and acceptable limits, serving as the objective ground truth against which the glove's performance was measured.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (examination glove) and does not involve AI or machine learning, thus no "training set" in that context was used. The manufacturing process itself (Good Manufacturing Practices, or GMPs) ensures consistency, and quality control (QC) testing of batches ensures compliance with standards.

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

This is not applicable for the same reasons as #8.

Ask a specific question about this device

The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

Powder-Free Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the NitriTech® Non-Sterile Powder-Free Nitrile Examination Gloves:

This document is a 510(k) summary for a medical device (examination gloves). As such, the "acceptance criteria" and "study" described are for the device itself and its physical properties and biocompatibility, not for an AI algorithm. Therefore, many of the questions related to AI-specific study design (like MRMC, standalone AI performance, training sets, expert qualifications for ground truth in AI) are not applicable.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

* Indicates data points explicitly marked with an asterisk in the source document, referencing "Third Party test data is available in Appendix A" or "Amendment F" (for biocompatibility).

Study Details (Applicable to Device Performance)

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

The document provides acceptance criteria from ASTM D6319-00a and CPSC/ISO standards. It states that the device "meets the ASTM D6319-00a Standard" and "meets... CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 requirements."

• Test Sets: The document refers to various ASTM test methods (D5151 for holes, D412/D573 for tensile properties, D6124-06 for powder content) and specific biocompatibility tests (CPSC Title 16 Chapter II Part 1500 for Primary Skin Irritation and ISO 10993-10 for Dermal Sensitization).
• Sample Sizes: The exact sample sizes for each specific test (e.g., how many gloves were tested for holes, how many animals for biocompatibility) are not explicitly specified in this summary document. It only provides the performance results.
• Data Provenance: The document states "Third Party test data is available in Appendix A" for the general performance tests and "Third Party test data is available in Amendment F" for biocompatibility. The biocompatibility tests were completed by "Mediamal Testing and Consultancy Services." The country of origin for the data is not specified beyond originating from this third-party testing entity. The studies are prospective in nature, as they involve actively testing new device samples.

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 to this type of device and study. The "ground truth" here is established by standardized physical and chemical tests (e.g., measuring glove dimensions, tensile strength, chemical content, biological reactions) rather than expert interpretation of complex data (like medical images). The "experts" would be the technicians and scientists performing the ASTM, CPSC, and ISO standardized tests, ensuring they follow the protocols correctly. Their qualifications are inherent in the accreditation of the third-party testing facility.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements or standardized biological assays, not subjective assessments requiring adjudication among multiple human readers.

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 (examination gloves), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. No AI algorithm is involved.

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

The ground truth is established by:

• Standardized Physical Measurements: Length, width, thickness, tensile strength, elongation are objective physical properties measured according to ASTM standards.
• Chemical Analysis: Powder content is determined by a chemical analysis method (ASTM D6124-06).
• Standardized Biological Assays: Primary Skin Irritation and Dermal Sensitization tests are conducted according to CPSC and ISO standards on biological models (animal testing as implied by the standards for such biocompatibility tests). The "ground truth" for irritation/sensitization is based on observing specific, quantified biological responses compared to established thresholds.

8. The sample size for the training set

Not applicable. There is no AI model or algorithm that requires a "training set" for these examination gloves. The device is evaluated based on its inherent physical and chemical properties.

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

Not applicable, as no training set exists for this type of device.

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