Search Results

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The qloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.

The provided text describes the acceptance criteria and performance of a medical device, specifically "Disposable Nitrile Medical Examination Gloves (Tested for Use with Chemotherapy Drugs)" (K212834). However, it is not an AI/ML medical device, but rather a physical product.

Therefore, many of the requested criteria for an AI/ML study (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set details, etc.) are not applicable to this document. The document details bench testing and biocompatibility assessments, which are standard for physical medical gloves.

Below is a table summarizing the acceptance criteria and reported device performance based on the provided document, along with a clarification of why other requested information is not present for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

Clarification regarding AI/ML specific questions:

The provided document is a 510(k) summary for a physical medical device (examination gloves), not an Artificial Intelligence/Machine Learning (AI/ML) based medical device. Therefore, the following requested information is not applicable to this submission:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for physical product testing. Performance testing is done via bench methods on manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (e.g., tensile strength, hole detection) is established through standardized laboratory test methods, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Testing involves measurable physical properties.
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 device, not an AI assistance tool.
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.): Ground truth for this device is based on standardized test methods and measurements (bench testing) per ASTM and ISO standards, not medical imagery or pathology.
8. The sample size for the training set: Not applicable. The device does not involve machine learning and therefore has no "training set."
9. How the ground truth for the training set was established: Not applicable.

In summary, the document details the safety and performance evaluation of a medical glove against established national and international standards for physical properties and biocompatibility. It successfully demonstrated substantial equivalence to a predicate device through these non-clinical tests.

Ask a specific question about this device

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

These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.

The provided document is a 510(k) summary for a medical device: "Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)". It details the non-clinical testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on your requested format:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• ASTM D6319 (Physical Dimensions, Tensile Strength, Ultimate Elongation): Data is reported for "Lot 1", "Lot 2", and "Lot 3". Each lot appears to represent multiple measurements across different sizes (XS, S, M, L, XL). The exact sample size per lot or per measurement (e.g., how many gloves were measured for length, width, thickness, or subjected to tensile tests) is not explicitly stated, but it follows the standard ASTM D6319 requirements for quality assurance.
• ASTM D5151 (Watertightness): The sample sizes are explicitly stated as 125 gloves per size: XS: 0/125 leaks, S: 1/125 leaks, M: 0/125 leaks, L: 0/125 leaks, XL: 0/125 leaks.
• ASTM D6124 (Powder Content): The sample size for powder content is not explicitly stated.
• ASTM D6978 (Chemotherapy Drug Permeation): The sample size for each drug test is not explicitly stated in the provided text.
• ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation, Sensitization): The sample sizes used for these biocompatibility tests are not explicitly stated, but the tests were conducted "under conditions of the study" which implies adherence to the standard's methodology.
• Data Provenance: All testing appears to be non-clinical (bench testing and laboratory biocompatibility tests). There is no information provided about patient data or country of origin for such data, as this is a device for which clinical testing was not deemed necessary. The testing was conducted in support of a device manufactured by Jiangsu Cureguard Glove Co., Ltd. in China.

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

Not applicable. The "ground truth" in this context is established by standardized physical, chemical, and biological testing methods (ASTM and ISO standards), not by individual expert consensus or interpretation of medical images. The results are objective measurements.

4. Adjudication method for the test set

Not applicable. The tests are based on objective measurements against predefined acceptance criteria from international standards. There is no element of subjective assessment requiring adjudication in the context of these non-clinical tests.

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 device is a medical examination glove, not an AI-powered diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical glove and does not involve any algorithm or AI component.

7. The type of ground truth used

The ground truth used for performance validation is based on standardized test methods and their defined performance criteria. Specifically:

• ASTM Standards: ASTM D6319 (physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (powder content), and ASTM D6978 (chemotherapy drug permeation). These standards define the procedures for measurement and the expected acceptable ranges or thresholds.
• ISO Standards (Biocompatibility): ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). These standards define the methods and parameters for assessing the biological safety of the device.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a "training set."

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

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

Ask a specific question about this device

The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Gloves (K210691)

The provided document describes the acceptance criteria and performance data for the Disposable Nitrile Medical Examination Glove (K210691) in comparison to the predicate device (K171422). The study primarily focuses on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

This document describes the premarket notification for the "Disposable Nitrile Medical Examination Glove". The acceptance criteria and the study proving the device meets these criteria are detailed through a series of tables and text.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is white. The subject device is non-sterile.

The provided document is a 510(k) summary for a Disposable Nitrile Medical Examination Glove. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. This document is not for an AI/ML medical device, but rather for a physical examination glove. Therefore, many of the requested criteria regarding AI/ML device acceptance, such as expert consensus, MRMC studies, training/test sets, and ground truth establishment, are not applicable to this submission.

However, I can extract and present the acceptance criteria and test results related to the physical and biocompatibility performance of the glove, as described in the document.

Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Glove (K210684)

The device, a "Disposable Nitrile Medical Examination Glove," is classified as Class I and its performance is evaluated against established ASTM and ISO standards for medical gloves, rather than complex AI/ML performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

• XS/S: ≥220
• M/L/XL: ≥230 | Length:
• XS/S: > 220/Pass
• M/L/XL: > 230/Pass |
  | | | Width (mm):
• XS: 70±10
• S: 80±10
• M: 95±10
• L: 110±10
• XL: 120±10 | Width:
• XS: 78-80 / Pass
• S: 85-89 /Pass
• M: 95-99/ Pass
• L: 105-111/ Pass
• XL: 115-120/ Pass |
  | | | Thickness (mm):
• Finger: ≥0.05
• Palm: ≥0.05 | Thickness:
• Finger: 0.09-0.13/Pass
• Palm: 0.07-0.13/Pass |
  | ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks / Pass |
  | ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124

Ask a specific question about this device