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The Disposable Nitrile 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 Pink/Cool Gary/Green/Rose Gold. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided document is a 510(k) premarket notification for a Disposable Nitrile Examination Glove. It details the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Nitrile 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 Black/Lavender/Navy Blue/Burgundy. It can be available in five specifications: XS,S,M,L and XL.

The subject device is non-sterile.

This document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove. It details the device's characteristics and compares it to a predicate device (K171422) to establish substantial equivalence.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The subject device is powder free vinyl patient examination gloves. During the production process, about 1% ~ 3% nitrile is added to the ingrove the tensile strength and ultimate elongation of the glove. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text is a 510(k) Summary for a medical device (Disposable Synthetic Vinyl Nitrile Examination Glove). It outlines acceptance criteria and test results for various non-clinical tests. Since the device is not an AI/ML powered device, the questions related to AI/ML powered devices are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

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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.

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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

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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

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Powder Free Vinyl Patient Examination Gloves, White Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves, White Color that meets all of the requirements of ASTM standard D 5250-06e1.

This document describes the acceptance criteria and performance for "Powder Free Vinyl Patient Examination Gloves, White Color".

1. Table of Acceptance Criteria and Reported Device Performance:

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Powdered vinyl 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 vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves (Light Yellow)." This is a medical device submission, specifically for patient examination gloves, which are low-risk devices. Therefore, the acceptance criteria and study design are different from what would be expected for a complex AI/ML diagnostic or prognostic device.

Here's the breakdown of the information based on your request, tailored to this type of device:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for pinholes, how many animals for biocompatibility). However, the tests are conducted according to established standards (ASTM, FDA regulations, ISO), which inherently define the sampling methods and acceptance levels.

• Provenance: This is a physical product (gloves), not data in the sense of patient records or images. The "data" provenance refers to the testing conducted on the manufactured gloves. There is no mention of country of origin for the data (testing results), but the manufacturer is based in China. The tests are non-clinical and would be considered prospective for the specific batch of gloves tested to support the submission.

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

• Not applicable in the context of this device. "Ground truth" usually refers to diagnostic accuracy in complex medical imaging or clinical decision-making. For these gloves, "ground truth" is established by direct measurement against a defined engineering or biological standard. For example, a pinhole is objectively present or absent based on a waterleak test. Biocompatibility tests are performed by trained laboratory personnel following established protocols, not by "experts" establishing a subjective ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. The tests are objective measurements against defined criteria (e.g., glove dimensions, force at break, waterleak test for pinholes, standardized biological assays). There is no subjective interpretation requiring adjudication.

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

• No. MRMC studies are used for evaluating diagnostic performance of imaging devices or algorithms with human readers. This device is a medical glove, not a diagnostic tool requiring interpretation by human readers.

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

• Not applicable. This device is a physical product (glove), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The "ground truth" for the acceptance criteria is defined by industry standards (ASTM D 5250-06, ASTM D6124-01) and regulatory requirements (21 CFR 800.20, ISO10993-10). This includes:
  • Engineering specifications: For dimensions, physical properties (tensile strength, elongation), and powder amount.
  • Physical test results: For freedom from pinholes (waterleak test).
  • Biological assay results: For biocompatibility (primary skin irritation and dermal sensitization tests in animal models).

8. The Sample Size for the Training Set:

• Not applicable. This is a manufactured product, without a "training set" in the AI/ML sense. The manufacturing process uses quality control, and the design itself is based on general engineering principles for glove production, not machine learning.

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

• Not applicable, as there is no "training set" for this device. The design specifications and manufacturing process are established based on the requirements of the ASTM standards and FDA regulations, informed by decades of glove manufacturing and material science.

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Powder free vinyl 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.

powder free vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes the 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves (Light Yellow)." As such, the information contained does not pertain to the development or validation of a medical AI device. Instead, it details the safety and effectiveness information for a physical medical device (examination gloves) compared to a predicate device.

Therefore, many of the requested sections about AI device validation criteria, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable to this document.

Here's an analysis of the available information based on the provided text, focusing on the acceptance criteria and the study (or tests) proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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Powder free vinyl 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.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)

Summary of Device Performance Study:

The provided text describes a premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies for Class I devices like examination gloves. The "study" in this context refers to the nonclinical tests conducted to prove the device meets established standards and is comparable to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

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