Search Results

First Glove Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

First Glove Blue Nitrile Examination Gloves Powder Free are equivalent to Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, finger textured, ambidextrous with beaded cuff and single use only.

This document describes the acceptance criteria and performance of the "First Glove Blue Nitrile Examination Gloves Powder Free" based on non-clinical testing.

Here's the information requested:

1. Table of acceptance criteria and the 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 individual test (e.g., number of gloves tested for dimensions, tensile strength, etc.). However, it indicates the tests were conducted according to the specified ASTM and ISO standards, which typically include defined sampling plans.

The data provenance is from non-clinical bench testing. The country of origin of the data is not explicitly stated in the provided text, but the applicant's address is Malaysia (First Glove Sdn. Bhd.).

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

This information is not applicable as the evaluation is based on non-clinical, objective laboratory tests against established international standards (ASTM and ISO). There were no human expert assessments of images or patient data to establish ground truth in this context.

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

None. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments. This submission relies on objective physical, chemical, and biological 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 is a submission for medical gloves, which are physical devices. MRMC comparative effectiveness studies are used for AI-powered diagnostic or interpretive tools, not for devices like gloves.

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

Not applicable. This is not an algorithm or AI-powered device.

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

The "ground truth" for the non-clinical tests is based on the objective and quantifiable criteria defined by the relevant ASTM and ISO international standards. For example, for tensile strength, the ground truth is a specific numerical value (e.g., ≥ 14 MPa). For biocompatibility, it's defined by biological endpoints (e.g., "non-irritant," "non-sensitizer," "non-cytotoxic").

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As mentioned above, there is no training set for this type of device.

Ask a specific question about this device

Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color, powder free and non sterile. The device is available in Extra Small, Small, Medium, Large and Extra Large sizes.

The provided document details the acceptance criteria for "Blue Nitrile Examination Gloves Powder Free" and presents the results of non-clinical testing to demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

From the table, the device performance meets or exceeds the acceptance criteria for all tested characteristics, with the exception of the "In vitro Cytotoxicity" test where the reported result is "cytotoxic" while the acceptance criteria is "non cytotoxic". This discrepancy needs clarification. However, in the "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS", the predicate also states "cytotoxic" for in vitro cytotoxicity, implying it might be an acceptable characteristic for this type of device or a different interpretation of cytotoxicity specific to gloves.

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 specific sample sizes used for each test. For example, for "Water Tight (1000 ml)" test, it mentions "Passes AQL-1.5", which implies a sampling plan was used according to the ASTM standard, but the specific number of gloves tested is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, beyond the fact that the tests were conducted according to international standards (ASTM, ISO).

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 information is not applicable. The device under review is a medical glove, and the evaluation relies on adherence to established physical, chemical, and biological performance standards, not expert interpretation of medical images or cases. Ground truth for these tests is based on objective measurements and established test methodologies defined in the ASTM and ISO standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., medical images) where expert consensus is required. The testing for this device involves objective, quantitative 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 a medical glove. MRMC studies are relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret images with or without AI assistance.

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

This information is not applicable. The device is a medical glove, not an algorithm or AI system.

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

The ground truth for this device's performance is based on the objective measurements and predefined thresholds within recognized international standards (ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ISO 10993-10, ISO 10993-5:2009, ISO 10993-11:2017, USP 41). For example:

• Dimensions: Measured length and width against minimum/range requirements.
• Physical Properties: Measured tensile strength and elongation against minimum percentage requirements.
• Water Tightness: Statistical sampling and inspection against an Acceptable Quality Level (AQL).
• Biocompatibility: Observation of biological responses (e.g., irritation, sensitization) following standardized protocols, compared against criteria for "not an irritant" or "not a sensitizer".

8. The sample size for the training set

This information is not applicable. The device is a medical glove, not an AI or machine learning model that requires 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 type of medical device.

Ask a specific question about this device

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs and Fentanyl Citrate. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The device is available in Small, Medium, Large and Extra Large sizes. The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)

The provided document is a 510(k) premarket notification for "Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate." This document outlines the acceptance criteria and the results of a study to demonstrate the device's performance.

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

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

The document provides extensive tables for the performance of the gloves. Rather than recreating the entire tables found on pages 10-14, a summary of key acceptance criteria and reported performance is presented below. Please refer to pages 10-14 of the original document for the complete lists of chemotherapy drugs and specific results.

Note on Cytotoxicity: The device itself is reported as cytotoxic under the tested conditions. This is a critical finding that does not meet a "Non cytotoxic" acceptance criterion. However, the FDA has still cleared the device. This implies that either the level of cytotoxicity observed is deemed acceptable for the intended use and risk-benefit profile of examination gloves, or mitigating factors/information were provided elsewhere (not in this summary). It's important to note this discrepancy.

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 lists various ASTM and ISO standards for testing, which define the sample sizes required for each test (e.g., AQL levels for watertightness). However, the specific quantity/sample size used for each individual test conducted by the manufacturer is not explicitly stated in this summary document beyond what's implied by the standard (e.g., AQL 1.5 for watertightness performance is a characteristic, not a sample size).

• Data Provenance: The manufacturing location of the device owner, JR Engineering & Medical Technologies (M) Sdn. Bhd., is in Malaysia (Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1, Pusat Perindustrian 2, 44200 Rasa, Hulu Selangor, Selangor Darul Ehsan, Malaysia). The testing was conducted in accordance with international standards (ASTM, ISO), implying that the data originates from laboratory studies, likely conducted by third-party labs or the manufacturer's own qualified labs, but the specific country of the testing labs is not mentioned.
• Retrospective or Prospective: The testing described is prospective laboratory performance testing of the device, rather than a retrospective analysis of existing data.

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 product is a medical glove, not an AI or imaging device requiring expert consensus for ground truth. The "ground truth" for this device's performance is established through objective, standardized laboratory testing (e.g., ASTM D6319 for physical properties, ASTM D6978 for chemical permeation, ISO 10993 for biocompatibility). These tests rely on chemical and physical measurements, not human expert interpretation of images or clinical outcomes. Therefore, the concept of "number of experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" is not applicable to this type of device. The "experts" are the technicians and scientists performing the standardized validation tests.

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

Not applicable. As this is not a study involving human interpretation of data where adjudication would be necessary (like in imaging diagnosis), there is no adjudication method described.

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 physical examination glove, not an AI or imaging diagnostic tool 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 is not an algorithm or AI device. The tests performed are "standalone" in the sense that they assess the intrinsic material properties and barrier performance of the glove itself.

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

The ground truth for this device is based on standardized, objective physical, chemical, and biological measurements obtained through laboratory testing, as defined by relevant ASTM and ISO standards. This includes:

• Physical measurements (e.g., length, width, thickness, tensile strength, elongation).
• Chemical analysis (e.g., residual powder, breakthrough detection time for drugs).
• Biological testing (e.g., irritation, sensitization, cytotoxicity, systemic toxicity, pyrogenicity).

8. The sample size for the training set

Not applicable. This device is a manufactured product (glove), not an AI algorithm or model that requires a "training set" of data.

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

Ask a specific question about this device

Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.

The provided text is a 510(k) summary for "Blue Nitrile Examination Gloves Powder Free". It details the device's characteristics, intended use, and a comparison to a predicate device. The document explicitly states that clinical testing is not applicable and that clinical data is not needed for gloves or for most devices cleared by the 510(K) process.

Therefore, there is no information in the provided text regarding a study that proves the device meets acceptance criteria related to AI or human-in-the-loop performance, as this is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool.

However, I can extract the acceptance criteria and reported performance for the non-clinical tests conducted on the device, which are relevant for demonstrating its substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Regarding the other requested information (2-9), as a physical medical device (gloves) and not an AI/software device, these questions are not applicable to the context of the provided document.

• 2. Sample size used for the test set and the data provenance: Not applicable. (These are physical tests on glove samples, not a test set for AI performance).
• 3. Number of experts and qualifications: Not applicable. (These are standardized physical and biological tests).
• 4. Adjudication method: Not applicable. (These are standardized physical and biological tests).
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted image interpretation or similar.
• 6. Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is for AI algorithms.
• 7. Type of ground truth used: Not applicable in the AI sense. The "ground truth" for these tests comes from established industry standards (ASTM, ISO, USP) for physical and chemical properties and biological responses.
• 8. Sample size for the training set: Not applicable. Applies to AI/machine learning.
• 9. How the ground truth for the training set was established: Not applicable. Applies to AI/machine learning.

Ask a specific question about this device

ComfortPro Blue Nitrile Examination Gloves Powder free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

ComfortPro Blue Nitrile Examination Gloves Powder Free is Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from Nitrile (NBR)100%. These gloves are blue in color, non-sterile, ambidextrous, powder free and single use only. Blue Nitrile Examination Gloves Powder Free are available in sizes X-small, Small, Medium, Large and X Large.

The provided document is a 510(k) summary for the ComfortPro Blue Nitrile Examination Gloves Powder Free. It describes the device, its intended use, and a comparison to a predicate device based on non-clinical performance data.

Here's the breakdown of the acceptance criteria and study information as requested:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for length, width, tensile strength, etc., or how many animals were used for biocompatibility tests). It only states they meet the relevant ASTM and ISO standards, which likely prescribe minimum sample sizes.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the manufacturer is "THAI RUBBER INDUSTRY COMPANY LIMITED" in Thailand, it is highly probable the testing was conducted in Thailand or by contractors on behalf of the Thai manufacturer. The nature of these tests (bench testing for physical properties and biocompatibility for materials) suggests they are prospective tests conducted on representative samples of the manufactured device.

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 question is not applicable to this type of device (nitrile examination gloves) and the studies performed. The "ground truth" for these tests are objective, measurable physical and chemical properties and biological responses, determined by standardized test methods (ASTM, ISO), rather than expert interpretation or consensus.

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly those involving interpretation of medical images or patient outcomes where subjective expert opinion is involved. The tests for these gloves 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 question is not applicable. MRMC studies are specific to medical imaging devices, often involving AI, to assess the impact of AI assistance on human reader performance. Examination gloves do not involve "readers" or "AI assistance" in this context.

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

• This question is not applicable. This concept applies to AI-driven algorithms. The ComfortPro Blue Nitrile Examination Gloves are physical medical devices.

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

• The "ground truth" is established by the defined specifications and test methods within the ASTM and ISO standards. For example, the "ground truth" for length is "Min 230 mm," and the test result is a direct measurement. Similarly, for biocompatibility, the "ground truth" is "not an irritant" or "non-cytotoxic," determined by specific biological assays.
• It's a combination of objective measurements compared against pre-defined normative standards.

8. The sample size for the training set

• This question is not applicable. The device is not an AI/ML algorithm that requires a "training set." The performance data is derived from testing physical samples of the manufactured gloves.

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

• This question is not applicable for the same reason as point 8.

Ask a specific question about this device

JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examination between patient and examiner.

Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

The subject device in 510(K) notification is JR Medic blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I).

The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)

I am sorry, but the provided text does not describe a study involving an AI device or algorithm, and therefore all the requested information about acceptance criteria, study design, sample sizes, ground truth, expert involvement, and MRMC studies cannot be extracted.

The document is a 510(k) premarket notification for "JR Medic Blue Nitrile Examination Powder Free Gloves tested for use with chemotherapy drugs." It details the non-clinical testing performed on these medical gloves to demonstrate their safety and effectiveness, specifically their resistance to permeation by chemotherapy drugs, in accordance with established ASTM (American Society for Testing and Materials) standards.

The document focuses on the physical, chemical, and biocompatibility properties of the gloves, not on the performance of a software algorithm or AI.

Ask a specific question about this device

SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free

This document describes the acceptance criteria and study results for SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free.

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 sample sizes used for each specific test listed (e.g., number of gloves tested for length, width, etc.). However, the tests are conducted in accordance with ASTM and ISO standards, which typically specify sampling plans.

The data provenance is from non-clinical tests conducted for the SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free. The manufacturer and exporter is SRIRUNGRUANG GLOBAL CO., LTD, located in Thailand. The studies are prospective as they were conducted specifically for this 510(k) submission to demonstrate substantial equivalence.

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

The document does not mention the use of experts or the establishment of ground truth in the context of clinical or diagnostic studies. The tests described are non-clinical, laboratory-based physical and biocompatibility assessments of the gloves. Therefore, the concept of "ground truth" established by experts, as it would be for diagnostic accuracy studies, is not applicable here. The "ground truth" for these tests is defined by the objective measurement criteria within the specified ASTM and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are non-clinical laboratory tests with objective pass/fail criteria based on established standards, not studies requiring expert adjudication of results.

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 not an AI-assisted diagnostic device, nor is it a study involving human readers or cases. It is a submission for patient examination gloves.

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on the specified quantitative and qualitative requirements of the referenced ASTM and ISO standards, such as minimum length, tensile strength, maximum powder residue, and the absence of irritation or sensitization. For the biocompatibility tests that showed cytotoxicity but no systemic toxicity concern, the "ground truth" was established through additional testing to confirm the lack of systemic risk.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (examination gloves), not a machine learning or AI model that requires a training set.

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

Not applicable. See point 8.

Ask a specific question about this device

Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.

The provided information is a 510(k) summary for "Blue Nitrile Examination Gloves Powder Free". This document describes the device and its equivalence to a predicate device, based on non-clinical performance testing. It does not describe a study involving an AI/Machine Learning driven medical device, human readers, or the establishment of ground truth by expert consensus for medical image interpretation or similar.

Therefore, most of the requested information regarding AI/ML device studies (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the non-clinical testing summary as requested for a physical device:

Acceptance Criteria and Device Performance for Blue Nitrile Examination Gloves Powder Free

This document describes the non-clinical performance of the "Blue Nitrile Examination Gloves Powder Free" and its substantial equivalence to a predicate device (K192333). The study performed is a series of laboratory tests to ensure the physical and chemical properties of the gloves meet established standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Finger
X-Small: 0.13mm
Small: 0.13mm
Medium: 0.14mm
Large: 0.13mm
X-Large: 0.14mm |
| ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 1.5 | Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | Residual Powder Content
X-Small: 0.21mg/glove
Small: 0.21mg/glove
Medium: 0.22 mg/glove
Large: 0.22 mg/glove
X-Large: 0.22 mg/glove |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14Mpa Minimal for all sizes
After Ageing: Tensile Strength 14Mpa Minimal for all sizes | Tensile Strength (Mpa)
Before Ageing
X-Small: 18.43
Small: 18.49
Medium: 18.54
Large: 18.57
X-Large: 18.64

After Ageing
X-Small: 17.49
Small: 17.51
Medium: 17.65
Large: 17.67
X-Large: 17.71 |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizes
After Ageing: Ultimate Elongation 400% Min for all sizes | Ultimate Elongation (%)
Before Ageing
X-Small: 685
Small: 688
Medium: 692
Large: 695
X-Large: 698

After Ageing
X-Small: 654
Small: 658
Medium: 661
Large: 665
X-Large: 669 |
| Biocompatibility (Primary Skin Irritation - ISO 10993-10:2010(E)) | Biocompatibility | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Biocompatibility (Dermal Sensitization - ISO 10993-10:2010(E)) | Biocompatibility | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| Biocompatibility (In vitro cytotoxicity - ISO10993-5:2009(E)) | Biocompatibility | (Predicate: Under the conditions of the study, cytotoxic) (Subject: Under the conditions of the study, non-cytotoxic) | Under the conditions of the study, non-cytotoxic |
| Biocompatibility (Acute Systemic Toxicity Test ISO 10993-11:2017(E)) | Biocompatibility | Under the condition of study not systemic toxic | Under the conditions of study, the device extracts do not pose a systemic toxicity concern |
| Biocompatibility (Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41) | Biocompatibility | Under the conditions of the study non pyrogenic | Under the conditions of the study non pyrogenic |
| Biocompatibility (Bacterial Endotoxin test USP 42) | Biocompatibility | (Predicate: No data available) (Subject:

Ask a specific question about this device

Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

JR MEDIC Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

The provided text is a 510(k) Premarket Notification for "Blue Nitrile Examination Gloves Powder Free." It details the device's technical characteristics, non-clinical performance, and comparison to a predicate device to demonstrate substantial equivalence.

This document describes the testing of a medical device (examination gloves), which
Does not involve AI, machine learning, or complex algorithmic performance in its functionality or assessment. The tests performed are
physical, chemical, and biological compatibility tests of the material itself.

Therefore, the requested information regarding acceptance criteria and study proving AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this document. The document describes the data and testing for a Class I medical device (gloves) and demonstrates its "substantial equivalence" to an existing predicate device, primarily through non-clinical bench testing and biocompatibility studies.

However, I can extract the acceptance criteria and reported performance for the physical and biological properties of the gloves, as provided in the document.

Acceptance Criteria and Reported Device Performance for Blue Nitrile Examination Gloves Powder Free

Since this is a physical medical device (gloves) and not an AI/ML-driven device, the criteria typically associated with AI/ML performance (e.g., AUC, sensitivity, specificity for a diagnostic algorithm) are not relevant here. Instead, the acceptance criteria relate to the physical properties, chemical composition, and biocompatibility of the gloves, demonstrating they meet established standards for medical examination gloves.

Here's the table of acceptance criteria and reported device performance based on the non-clinical testing summary:

1. Table of Acceptance Criteria and Reported Device Performance

Since the device is a simple medical examination glove and not an AI/ML system, the following points regarding AI/ML study design are explicitly not applicable to the data provided in this document:

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on physical and chemical tests on manufactured gloves, not a "test set" of patient data for AI.
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 gloves is defined by adherence to physical standards (ASTM) and biological safety (ISO, USP), not expert annotation of medical images/data.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for performance assessment of diagnostic/AI tools with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" here is compliance with established international standards for physical properties and biocompatibility of medical gloves.
8. The sample size for the training set: Not applicable. There is no training set as there is no AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device