Search Results

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

These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a Nitrile Butadiene Rubber, blue in color, powder free and non-sterile (per 21 CFR Part 880.6250, class I). The device meets all the specifications in ASTM D6319-10. Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.

The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is designed to be used for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between the patient and the examiner (product code LZA). In addition, these gloves were tested for use with chemotherapy drugs (product code LZC) in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

The provided document is a 510(k) Premarket Notification for a medical device, specifically the "SHOWA® Blue Nitrile Powder Free Medical Examination Glove." It outlines the acceptance criteria and the studies performed to demonstrate the device's substantial equivalence to a predicate device.

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 specific test (e.g., number of gloves tested for dimensions, tensile strength, or chemotherapy permeation). It references specific ASTM and ISO standards for testing, which typically define the appropriate sample sizes and testing methodologies. The data provenance (country of origin, retrospective/prospective) is not mentioned.

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 is not applicable to this type of device submission. The "ground truth" for medical gloves is established by quantitative laboratory testing against defined material and performance standards (ASTM, ISO). There are no human experts judging images or clinical outcomes in this context.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) to resolve disagreements. Here, the "truth" is determined by objective physical and chemical testing.

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. MRMC studies are typically performed for AI-powered diagnostic devices that assist human readers. This submission is for a physical medical device (examination glove).

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

This is not applicable. There is no algorithm involved; it is a physical device.

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

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

• Dimensions, Physical Properties (Tensile Strength, Elongation), Freedom from Holes, Residual Powder: Defined by the ASTM D6319-10 standard.
• Biocompatibility (Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): Defined by ISO 10993-10 and ISO 10993-11 standards.
• Resistance against Chemotherapy Drugs: Defined by ASTM D6978-05 standard.
• Open box bioburden: Defined by AAMI 11737-1.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The performance is assessed through direct testing of the product.

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

This is not applicable as there is no training set.

Ask a specific question about this device

The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. The gloves are single use only, supplied in a nonsterile state, and come in six (6) sizes: XS, S, M, L, XL, and XXL. The gloves are made of Nitrile Butadiene Rubber, designed, and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Their physical and performance characteristics meet all requirements of ASTM D6319-10. The gloves are powder-free and meet the requirements of ASTM D6124-06. No powder is used during any stage of manufacturing. Rather, the gloves are manufactured using online chlorination - a process wherein the examination gloves are dipped in a dilute chlorine solution to reduce surface friction. More specifically, through the chlorination reaction, the compound is stabilized and further cross-linked and the gloves' surface becomes hardened and smooth, thereby providing the gloves with good donning properties. The gloves then are removed from the chlorination solution and neutralized in an aqueous ammonia solution and washed until any residual chlorine is removed, resulting in the gloves' surface pH being similar to that of water. Once the wash process is completed, the reactive material is removed, thus ceasing the chlorination process.

The document describes the non-clinical testing and acceptance criteria for the "Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove" (K190159). The study aimed to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (K082125).

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

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

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

The SBG Black Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a nitrile latex compound, black in color, powder free and non-sterile.

The provided document is a 510(k) Pre-Market Notification for a medical device, specifically the "SBG Black Nitrile Powder Free Medical Examination Glove" (K180468).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison table (page 5) between the proposed device (SBG Black Nitrile Powder Free Medical Examination Glove, K180468) and a predicate device (EMG Black Nitrile Medical Examination Glove Powder Free, K141579). This table serves as the primary source for acceptance criteria and reported performance for the proposed device, demonstrating equivalence to the predicate.

Note on "Acceptance Criteria": For characteristics where a numerical value is given (e.g., Tensile Strength), that is the explicit acceptance criteria. For qualitative characteristics (e.g., Material Use, Color), the "Acceptance Criteria" column reflects the shared characteristic with the predicate or a general industry expectation. For biocompatibility and safety assessments, the criteria are implied to be "not a primary skin irritant," "not a contact sensitizer," and "low potential health risk," respectively.

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

The document refers to various ASTM and ISO standards for testing (e.g., D 412, D 573, D 5151, D 6124, ISO 10993-10:2010 (E)). These standards often specify sample sizes for their respective tests. However, the exact sample sizes used for each test performed on the proposed device are not explicitly stated in this summary.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is assumed these were prospective tests performed by the manufacturer or contracted labs to verify the device's conformance to standards.

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

This type of information is not applicable to the evaluation of this device. The device is a "Patient Examination Glove," which is a Class I device and its performance is assessed through physical, chemical, and biological testing against established standards, not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human interpretation or subjective assessments. The tests for a medical examination glove are objective measurements against predefined standards.

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 device is an examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This information is not applicable. As mentioned above, the device is a physical examination glove, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established national and international standards for medical examination gloves (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10). These standards define the acceptable physical properties (tensile strength, elongation, dimensions), freedom from holes, residual powder levels, and biocompatibility.

8. The sample size for the training set

This information is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical product and does not involve machine learning.

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

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

The SBG Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a nitrile latex compound. Blue in color, powder free and non-sterile.

The provided document is a 510(k) summary for a medical device called "SBG Blue Nitrile Powder Free Medical Examination Glove." This document outlines the device's characteristics, its comparison to a predicate device, and the results of various non-clinical tests to demonstrate substantial equivalence.

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:

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 (e.g., freedom from holes, physical properties, biocompatibility) or their data provenance (country of origin, retrospective/prospective). However, for tests like "Freedom from Holes (D 5151)," it mentions an "AQL 2.5 Inspection Level G-1," which implies a statistically defined sampling plan as per ASTM D5151-06. The standard for biocompatibility tests (ISO 10993-10) also specifies testing guidelines.

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. The document describes non-clinical tests (physical properties, biocompatibility) of a medical examination glove, which typically rely on standardized testing protocols rather than expert consensus on a test set (as would be the case for AI/imaging devices).

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation or subjective assessments, particularly in AI models for medical imaging. The tests described here are objective, quantitative measurements of material properties and biological responses.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic or interpretive tools to assess how human readers' performance changes with AI assistance. The device in question is a physical glove, not an AI diagnostic tool.

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

No, a standalone study as defined for AI algorithms was not done. The device is a physical product, and its performance is evaluated based on its material properties and safety characteristics, not an algorithm's output.

7. The Type of Ground Truth Used:

The "ground truth" for the tests described are objective physical and chemical measurements and biological responses as defined by specific ASTM and ISO standards. For example:

• Freedom from Holes: Defined by the ASTM D5151-06 standard and its specified AQL (Acceptance Quality Limit).
• Tensile Strength & Ultimate Elongation: Measured according to material testing standards.
• Residual Powder: Measured according to ASTM D6124.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization): Determined by standardized animal or in-vitro tests following ISO 10993-10:2010 (E) protocols. The outcomes (e.g., "not a primary skin irritant") serve as the ground truth based on the established biological criteria of these tests.

8. The Sample Size for the Training Set:

This concept is not applicable to this device. A "training set" is used for machine learning algorithms. This device is a physical glove, not an AI model, and therefore does not have a training set.

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

This information is not applicable as there is no training set for this device.

Ask a specific question about this device

The N-DEX® BWC™ Pink Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner. (21 CFR 880.6250)

This device has been tested for use with specific chemotherapy drugs. This device is not intended to be used as a chemical barrier.

The N-DEX® BWC™ Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.

This 510(k) submission describes the N-DEX® BWC™ Nitrile Powder-Free Medical Examination Glove (pink) and its substantial equivalence to a predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical examination glove, and its performance is evaluated against established ASTM standards and biocompatibility tests.

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

• Test Set Sample Size: The document does not explicitly state the sample sizes used for each ASTM standard test or biocompatibility study. However, these standards typically specify minimum sample sizes for testing to achieve statistically significant results.
• Data Provenance: The studies were conducted by Best Glove, Inc. and are considered retrospective in the sense that the data is presented to demonstrate conformance to existing standards rather than generated from a new clinical trial. The country of origin for the data is not explicitly stated, but given the company's US address and compliance with ASTM and ISO standards, it is highly likely the testing was performed in the US or in accredited labs adhering to international standards.

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

This type of submission for a medical glove does not involve establishing ground truth from human expert consensus in the way an AI diagnostic device would. Instead, ground truth for material properties is established by adherence to validated ASTM and ISO test methods performed in laboratories. The "experts" involved would be qualified laboratory technicians, engineers, and scientists specialized in materials testing and biocompatibility. Their qualifications would be based on their expertise in performing and interpreting these specific tests according to regulatory and industry standards.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. The conformance to standards is determined by objective laboratory measurements and interpretations of those results against the criteria defined by the respective ASTM and ISO standards. There is no ambiguous result that requires human adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. For a medical examination glove, the "effectiveness" is primarily determined by its physical properties and biocompatibility, as measured by standard laboratory tests, not by human reader performance.

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

Yes, the performance evaluation in this submission is effectively a "standalone" evaluation of the glove's physical and biological properties. The tests (ASTM for physical properties, ISO for biocompatibility) are objective measurements of the device itself, without any human-in-the-loop diagnostic or interpretive component.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Standardized Test Methods and Specifications: Conformance to specific ASTM and ISO standards (e.g., ASTM D 6319-00a for glove properties, ISO 10993 for biocompatibility). These standards define objective, measurable criteria for acceptable performance.
• Predicate Device Performance: The primary ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Ultimate N-DEX® Nitrile Powder-Free Medical Examination Glove, Non-Sterile (blue), K001375). The proposed device must meet or exceed the performance of the predicate device for relevant parameters.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" in the context of manufacturing would relate to process control and quality assurance to ensure consistent product attributes, not a data-driven training of a model.

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

Not applicable. As noted above, there is no AI/ML training set for this device.

Ask a specific question about this device

The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).

The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.

Here's an analysis of the provided 510(k) submission, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove (Non-Sterile)

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 used for the non-clinical performance tests (ASTM standards) or the biocompatibility tests (ISO standards). The results are reported as "Conforms," "Passes," or "Not tested," implying that the testing was conducted according to the methodology outlined in the respective standards.

For biocompatibility, the tests were conducted, but the specific number of animals or human subjects (if applicable for irritation/sensitization under specific protocols) is not provided.

The data provenance is from testing conducted by the manufacturer, Best Glove, Inc. No country of origin for the data is specified beyond the company's location in the USA. The tests are prospective as they were conducted to demonstrate the safety and effectiveness of the new device for the 510(k) submission.

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

This submission does not involve an expert-reviewed test set in the way a medical image analysis or diagnostic device might. The "ground truth" for this device (medical examination glove) is established by its adherence to established performance standards (ASTM) and biocompatibility standards (ISO).

Therefore, there were no "experts" in the traditional sense involved in establishing a ground truth for a test set for diagnostic accuracy. Instead, the "ground truth" is defined by the passing criteria of the specified international standards for glove performance and safety. The expertise lies in the certified laboratories and personnel who conduct these standardized tests according to the established protocols.

4. Adjudication Method for the Test Set

Not applicable. This device is not a diagnostic tool requiring expert adjudication of results. The performance and biocompatibility tests are based on objective measurements and established pass/fail criteria within the relevant ASTM and ISO standards.

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 is relevant for diagnostic devices where human readers interpret data (e.g., medical images) and AI might assist in that interpretation. This submission is for a medical examination glove, which does not involve human readers interpreting diagnostic information.

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 an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used is based on established objective performance criteria and biocompatibility thresholds defined by recognized international standards:

• Performance: ASTM D 6319-00a/06, ASTM D 6124-01/06, ASTM D 5151-99/06. These standards define physical properties like tensile strength, elongation, puncture resistance, and watertightness, with specific acceptance limits.
• Biocompatibility: ISO 10993-10 (for irritation and sensitization) and ISO 10993-5 (for cytotoxicity). These standards define acceptable biological responses when the device comes into contact with tissues.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical glove and does not involve a "training set" in the context of machine learning or AI algorithms. The manufacturing process and quality control are based on established engineering principles and quality management systems, not data training.

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

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

Ask a specific question about this device