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A 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.

Powdered Nitrile Examination Gloves, Blue

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powdered Nitrile Examination Gloves, Blue". This document does not contain information about acceptance criteria and a study proving the device meets those criteria, as it pertains to a medical glove. The type of information requested (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) is typically found in submissions for AI/ML-based medical devices or diagnostic tools, not for a physical device like examination gloves.

Therefore, I cannot fulfill your request based on the provided text.

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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.

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

Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance data for "Powdered Nitrile Examination Gloves" by SPI GLOVES SDN. BHD. This is a medical device and the information is presented as part of a 510(k) summary submitted to the FDA.

Here's a breakdown of the requested information:

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

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Not Found

This document is a 510(k) clearance letter from the FDA for medical gloves, and it does not contain the type of information requested in the prompt. The request asks for details about a study and acceptance criteria for a device, which typically refers to a diagnostic or therapeutic device whose performance is measured against specific metrics.

This document, however, is solely about the regulatory clearance of "NITRI GRIP Powdered Nitrile Examination Gloves" and confirms their substantial equivalence to predicate devices, thus allowing them to be marketed. It does not include:

• A table of acceptance criteria and device performance.
• Details about a test set (sample size, data provenance, ground truth experts, adjudication).
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on a training set or how ground truth for training was established.

The "Indications for Use" section (page 2) simply states the purpose of the gloves, which is to prevent contamination between healthcare personnel and patients, not a performance metric for which a study with acceptance criteria would be conducted in the context of the prompt's questions.

Therefore, I cannot fulfill the request based on the provided document.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.

Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.

This document describes the acceptance criteria and performance of the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue and Green).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each test. However, the performance data is based on the ASTM D3578-95 standard and the FDA 1000 ml watertight test, which would typically specify sampling plans. The data provenance is from SEAL POLYMER INDUSTRIES SDN. BHD. in Lahat, Perak, Malaysia. The study appears to be a retrospective analysis of product performance against established standards.

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

This information is not provided in the document. For product performance testing against standard specifications like ASTM D3578-95, the "ground truth" is typically defined by the objective measurement procedures within the standard, not by expert consensus on individual cases.

4. Adjudication method for the test set:

Not applicable. The performance data is based on objective measurements and compliance with a standard (ASTM D3578-95) and FDA requirements, not on subjective interpretations requiring 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. This is a submission for a medical glove, a physical device, and not an AI-powered diagnostic or decision support tool that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth used for performance evaluation is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-95 Standard for Rubber Examination Gloves.
• FDA 1000 ml watertight test for pinhole requirements.
• FDA requirements for minimum powder residual content.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. This is a physical medical device.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.

Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance of "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Blue)" and "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Green)" as detailed in the K993133 510(k) submission.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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POWDERED NITRILE EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

POWDERED NITRILE EXAMINATION GLOVES

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Powdered Nitrile Examination Gloves", indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classifications, general controls, and good manufacturing practices, but not specific performance acceptance criteria or study details.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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