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This Nitrile 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, and has also been Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.

Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid

This document describes the Violet Nitrile Powder Free Patient Examination Glove. However, it is a 510(k) premarket notification for a medical device (a glove), not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and studies related to AI/ML device performance (sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, standalone performance) is not applicable to this document.

The document focuses on the glove's performance with various chemotherapy drugs and fentanyl, and provides test results based on ASTM D6978-05 (2019) for breakthrough times.

Here is the information from Section {2} that is relevant to the glove's performance:

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

The document does not explicitly state "acceptance criteria" in a separate section. However, the reported "Minimum Time Breakthrough" values serve as the device's performance against the challenge of different chemicals. The implicit acceptance criterion for a protective glove would be a sufficiently long breakthrough time. The significant warnings for Carmustine and Thiotepa suggest that their breakthrough times are below a desired protective threshold for those specific chemicals.

Warnings:

• Carmustine and Thiotepa: Have extremely low permeation times of 23.2 min and 67.0 min respectively.
• Not for Use With: Carmustine or Thiotepa.

2. Sample size used for the test set and the data provenance: Not applicable to an AI/ML device. The data shown is chemical permeation testing data for a physical product (glove). The standard ASTM D6978-05 specifies the testing methodology, including sample sizes for physical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to an AI/ML device. The "ground truth" here is the chemical breakthrough time, which is measured mechanically/chemically according to a standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to an AI/ML device. This refers to human expert judgment in AI model validation.

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/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the glove's performance is experimentally measured chemical breakthrough time as per the ASTM D6978-05 standard.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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This Nitrile 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, and has also been Tested for Use with the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.

Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid

This document is a 510(k) premarket notification decision letter from the FDA for a medical device: "Black Nitrile Powder Free Patient Examination Glove". It does not describe an AI/ML powered device, therefore, the requested information regarding acceptance criteria and study details for an AI-based device is not applicable and cannot be extracted from this document.

The document focuses on:

• The FDA's determination of substantial equivalence for the glove to legally marketed predicate devices.
• The regulatory classification and applicable regulations for the device.
• A table of test results for the glove's resistance to various chemotherapy drugs, fentanyl citrate, and simulated gastric acid, along with breakthrough times. This is performance data for the physical glove, not an AI model.

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A 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.

Nitrile Powder Free Patient Examination Glove, Black Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device: "Black Nitrile Powder Free Patient Examination Glove, Non Sterile". This document focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a clinical trial for novel device performance.

Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment for a diagnostic algorithm (which is typical for AI/ML device submissions) is not applicable to this specific registration. This document describes the physical and chemical properties of a medical glove.

However, I can extract the acceptance criteria and reported device performance from the non-clinical testing performed to show equivalence with existing standards for examination gloves.

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

Further Requested Information (Not Applicable or Not Provided for this Device Type):

The following points are specifically relevant for AI/ML-powered diagnostic or decision support devices, which is not what this FDA submission is for. This document is for a physical medical glove. Therefore, the requested information below is not present in the provided text.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a physical medical glove. The non-clinical tests involved sampling of gloves for physical and chemical property testing.
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): Not applicable. Ground truth for physical properties is established through standardized laboratory testing protocols, not expert consensus on diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove, the "ground truth" is defined by the technical specifications and testing methods in the ASTM and ISO standards (e.g., a hole is a hole if water leaks, tensile strength is measured by a specific test).
8. The sample size for the training set: Not applicable. There is no AI model or algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

Conclusion from document:

The provided document describes the non-clinical testing of a "Black Nitrile Powder Free Patient Examination Glove, Non Sterile" to demonstrate its substantial equivalence to a predicate device (K190942). The tests show that the glove meets or exceeds the requirements of relevant ASTM and ISO standards for physical properties, dimensions, watertight integrity, residual powder, and biocompatibility, thus clearing it for market. No clinical studies or AI/ML algorithm evaluations were part of this 510(k) submission.

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A 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.

Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

The provided text describes the acceptance criteria and performance data for the "Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile". This is a medical device, and the data presented relates to its physical properties and biocompatibility, not an AI/ML-based device. Therefore, questions related to AI/ML specific aspects like expert adjudication, MRMC studies, standalone algorithm performance, and training set details are not applicable.

Here's the analysis based on the provided text, focusing on the relevant criteria for this type of medical device:

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

• Physical Properties (Tensile Strength, Ultimate Elongation, Dimensions): The sample sizes are not explicitly stated for each specific test, but ASTM D412 and ASTM D3767 standards typically specify sample sizes for these types of tests.
• Watertight: The sample size used was 315 pieces (based on inspection level G1 for a batch size of 150,001 to 500,000 under AQL 1.5).
• Residual Powder: The sample size used was 5 pieces.
• Biocompatibility: The specific sample sizes for in vivo tests (like primary skin irritation, dermal sensitization, acute systemic toxicity) are not explicitly mentioned in terms of number of animals, but the standards (ISO 10993-10, ISO 10993-11) outline the appropriate sample sizes and methodologies for these studies.
• Data Provenance: The data is non-clinical test data conducted by Onetexx Sdn Bhd (Malaysia), indicated by the submitter's address. These are prospective tests performed on the device to demonstrate compliance with standards.

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

This question is not applicable. The device is a patient examination glove, and its performance is assessed through standardized physical and chemical tests (e.g., tensile strength, watertightness, biocompatibility), not through expert interpretation of medical images or other data requiring "ground truth" established by human experts.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML performance studies, especially when human interpretation is involved. For physical and chemical testing of medical gloves, results are determined by adherence to established test procedures and measurement against quantitative 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 question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device is established by objective measurements and standardized test procedures defined by ASTM and ISO standards (e.g., ASTM D412 for tensile properties, ASTM D5151 for watertightness, ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for this product's performance evaluation.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device, and therefore does not have a "training set."

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

This question is not applicable as this is not an AI/ML device, and therefore does not have a "training set."

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A 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.

White Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

The provided text describes the acceptance criteria and performance of the White Nitrile Powder Free Patient Examination Glove, Non-Sterile (K210775).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Properties (Tensile Strength, Ultimate Elongation_): No specific sample size for a test set is provided beyond the general understanding that testing was conducted per ASTM D412. The results are reported as single values (e.g., 32.35 MPa), implying these are average or representative values from tests.
• Dimension: Not explicitly stated, but measurements for XS, S, M, L, XL sizes are provided.
• Watertight:
  • Sample Size: A batch size of 150,001 to 500,000 gloves was considered for sampling.
  • Actual Sample Drawn: 315 pieces as per single sampling plan GI for AQL 1.5.
• Residual Powder:
  • Sample Size: 5 pieces.
• Biocompatibility:
  • Specific sample sizes for Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, and Acute Systemic Toxicity are not provided in the summary but typically involve animal testing (e.g., guinea pigs for sensitization).

Data Provenance: Not explicitly stated, but the testing would have been conducted by Onetexx Sdn Bhd (the submitter) or a contracted lab to meet the specified ASTM and ISO standards. Given the manufacturer's address in Malaysia, it is likely the testing was conducted in Malaysia or a recognized testing facility accessible to them. The studies are non-clinical (device performance tests).

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

Not applicable. This submission pertains to physical and biocompatibility testing of a medical glove, which relies on standardized objective test methods (ASTM, ISO) rather than expert consensus on interpretation. The "ground truth" is defined by the acceptance criteria set forth in these standards.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against established technical standards, not 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 patient examination glove, not an AI-powered diagnostic or assistive device.

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

Not applicable. This is for a physical medical device (glove), not a software or algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on objective measurements and adherence to established industry standards (ASTM, ISO) and regulatory requirements (21 CFR 880.6250). For example:

• Physical properties (tensile strength, elongation, thickness) are measured against numerical thresholds defined by ASTM D412 and ASTM D3767.
• Watertight integrity is assessed against the Acceptance Quality Limit (AQL) defined by ASTM D5151.
• Residual powder is measured against a quantitative limit in ASTM D6124.
• Biocompatibility (skin irritation, sensitization, cytotoxicity, systemic toxicity) is evaluated based on the criteria specified in ISO 10993 series, which typically involve observing biological responses in test models and determining if they meet "non-irritant," "non-sensitizer," or "no systemic toxicity" classifications.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no "training set" for this type of device.

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A 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.

Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

This document is a 510(k) premarket notification for a disposable patient examination glove. This type of device does not typically involve AI components or complex clinical studies for its clearance. Therefore, a significant portion of the requested information, particularly regarding AI development, ground truth establishment, expert consensus, and MRMC studies, is not applicable to this document.

Here's the information that can be extracted from the provided text, aligning with the categories requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: For characteristics like dimensions and biocompatibility, the provided text often states "Similar" or "Same" without explicitly detailing identical acceptance criteria across both tables presented, but it's implied that the new device meets the same underlying standards as the predicate.

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

• Physical Properties: The sample size for physical properties testing (tensile strength, elongation) is not explicitly stated numerically, but the tests were performed "Before Aging" and "After Aging" according to ASTM D412.

• Watertight Test:

  • Sample Size: 315 pieces (referencing a single sampling plan G1 for a batch size of 150,001 to 500,000, with AQL 1.5).

• Residual Powder:

  • Sample Size: 5 pieces

• Biocompatibility Tests: Sample sizes for these tests (e.g., number of animals for irritation/sensitization, cells for cytotoxicity) are not specified in this document but are part of the respective ISO standards.

• Data Provenance: The testing was conducted by Onetexx Sdn Bhd, a manufacturer based in Kamunting, Perak, Darul Ridzuan, Malaysia. The data is prospective, generated specifically for this 510(k) submission.

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

Not applicable. This device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM and ISO), not through expert interpretation of data.

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

Not applicable. The evaluation relies on standardized test methods with objective measurements, not subjective interpretation 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 device is a medical glove, it does not involve AI or human "readers" in the context of diagnostic interpretation.

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

Not applicable. This device does not have an algorithm or AI component.

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

The "ground truth" for this device is defined by the objective thresholds and methodologies specified in internationally recognized standards (ASTM D6319, ASTM D412, ASTM D3767, ASTM D6124, ASTM D5151, ISO 10993 series). These standards outline accepted levels of performance for physical properties, dimensions, watertightness, residual powder, and biocompatibility.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not involve a training set.

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