Search Results

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.

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

The document is a 510(k) Premarket Notification for "Latex Examination Gloves Powder Free". It does not describe an AI/ML medical device, therefore, the requested information for acceptance criteria and study details for such a device is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K152593) for patient examination gloves.

However, I can extract the acceptance criteria and performance of the device based on the non-clinical tests mentioned, as they serve a similar purpose of demonstrating safety and effectiveness for this medical device.

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 sample sizes for each specific test (e.g., how many gloves were tested for length, thickness, or tensile strength). However, the tests were performed "as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20." These standards typically define the sampling plans. The data provenance is Malaysia, as the applicant, Careglove Global SDN BHD, is located in Seremban, Negeri Sembilan, Malaysia. The tests are non-clinical and would be considered prospective in the sense that they were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device that requires expert ground truth for image or data interpretation. The ground truth for the glove's performance is established by objective measurements against established industry standards (ASTM D3578-05).

4. Adjudication method for the test set
Not applicable, as it's not an AI/ML device requiring human adjudication of performance. The performance is determined by direct physical and chemical measurements.

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
The ground truth is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-05 (Standard Specification for Rubber Examination Gloves)
• 21 CFR 800.20 (dealing with devices that prevent contamination)
• ISO 10993-10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

These standards define the acceptable performance limits for the characteristics tested.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth for it. The ground truth for the device's performance is established by the aforementioned ASTM and ISO standards for physical characteristics and biocompatibility.

Ask a specific question about this device

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

LATEX EXAMINATION GLOVE POWDER FREE

This document is a 510(k) premarket notification letter from the FDA regarding a Latex Examination Glove Powder Free. It does NOT contain information about acceptance criteria, device performance, a study, or any of the specific details requested in your prompt (such as sample size, data provenance, ground truth, or MRMC studies).

This document is solely an approval letter for a medical device that falls under general controls.

Ask a specific question about this device

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

Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

The provided text is for a 510(k) Premarket Notification for a medical device, specifically a Powder Free Latex Patient Examination Glove. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and comparison of technological characteristics, rather than extensive clinical studies as one might find for a novel diagnostic AI device.

Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and submission. The "study" here refers to the testing performed to meet specific ASTM standards and biocompatibility requirements.

Here's a breakdown of the information that is applicable and how it relates to the acceptance criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are defined by existing ASTM standards and biocompatibility testing. The device's performance is reported as meeting these standards.

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

The document specifies that the device "meets all the current specification for ASTM D3578-05 (2010)" and refers to other ASTM and ISO standards for specific characteristics. Clinical data was "not needed for market cleared examination gloves."

• Sample Size for Test Set: The specific sample sizes for each test (e.g., pin-holes, dimensions, physical properties) are not detailed in this 510(k) summary. These would typically be specified within the individual ASTM and ISO standards referenced. For example, ASTM D5151-99 for freedom from pinholes often specifies a sample size based on the acceptable quality level (AQL).
• Data Provenance: The document does not explicitly state the country of origin for the data (e.g., where the tests were physically conducted) nor whether it was retrospective or prospective. Given the nature of performance testing against standards, it would be prospective testing of newly manufactured glove batches. The manufacturer is "Top Calibre Sdn Bhd" in Selangor, Malaysia, so the testing was likely conducted by or for them.

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

Not Applicable: This type of device does not involve a "ground truth" established by experts in a diagnostic or interpretive sense. The ground truth for performance characteristics is defined by the objective measurement criteria within the relevant ASTM and ISO standards (e.g., tensile strength, elongation, water leak rate, protein content measurement). Biocompatibility tests are performed by qualified laboratories and assessed against established toxicology criteria.

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

Not Applicable: Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, often in diagnostic imaging or clinical trials, to resolve discrepancies between readers. For physical and chemical tests of gloves, results are objectively measured against defined thresholds in the standards; there is no 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 patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and assessments of AI assistance are irrelevant.

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

Not Applicable: This device is a physical medical device (glove), not an algorithm or software. Standalone algorithm performance is not relevant.

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

The "ground truth" for this device's performance is established by objective measurements against predefined criteria and thresholds set forth in the referenced ASTM and ISO standards.

• For Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Protein Content: The ground truth is the quantitative measurement of these properties (e.g., thickness, tensile strength, percentage of gloves passing water leak test, specific protein content in µg/dm²) compared to the specified limits in standards like ASTM D3578-05 (2010), ASTM D5151-99 (2006), ASTM D6124-06, and ASTM D5712-10.
• For Biocompatibility: The ground truth is determined by the results of standardized biological tests (Dermal Sensitization and Primary Skin Irritation Tests as per ISO 10993-10:2010), which assess the device's potential to cause adverse biological reactions. The "ground truth" in this context is the observation of whether a reaction occurs and its severity, interpreted against established toxicity criteria, leading to a "pass" or "fail" determination (e.g., "Not a contact skin sensitizer," "Not a primary skin irritant").

8. The sample size for the training set

Not Applicable: This device does not use machine learning or AI, so there is no "training set."

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

Not Applicable: As there is no training set, this question is not relevant.

Ask a specific question about this device

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

Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

Acceptance Criteria and Device Performance Study for K120693 - Powdered Latex Patient Examination Glove

This document describes the acceptance criteria and the study demonstrating that the "Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm² of glove or Less of Water Extractable Protein)" (K120693) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established ASTM standards and ISO standards for biocompatibility.

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

The document does not explicitly state the sample sizes used for each specific test or the country of origin for the data. However, the evaluation relies on compliance with established ASTM and ISO standards, which typically involve specific sampling plans and test methods. The studies are non-clinical performance tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of medical device (patient examination gloves), the "ground truth" is established by adherence to recognized national and international consensus standards (ASTM and ISO), not by expert consensus on clinical data or image interpretation. The tests are laboratory-based and objective measurements.

4. Adjudication Method for the Test Set

Not applicable. The performance testing involves objective measurements against established standard specifications, not subjective interpretation requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a patient examination glove, and its performance is assessed through non-clinical laboratory testing against physical, chemical, and biocompatibility standards. MRMC studies are typically relevant for diagnostic imaging or similar devices that involve human interpretation of results.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done in the sense that the device itself, a physical product, was subjected to a series of laboratory tests to evaluate its inherent characteristics against the specified standards. Human interaction is limited to conducting the tests according to the standard protocols and recording the objective results.

7. Type of Ground Truth Used

The ground truth used is based on established national and international consensus standards (ASTM and ISO). These standards define objective pass/fail criteria and test methodologies for dimensions, physical properties, freedom from pinholes, powder amount, protein content, and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an algorithm or AI model that requires a training set. The evaluation is based on direct testing of the manufactured product batches against standardized criteria.

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

Not applicable, as there is no "training set" for this device. The ground truth for evaluating the device's performance is established by the specified ASTM and ISO standards themselves, which outline the acceptable ranges and test methods.

Ask a specific question about this device

A powder-free patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner

Latex Examination Gloves Powder-Free (Black Color) and with protein content labeling claim(50 micrograms or less)

This document is a 510(k) premarket notification determination letter from the FDA for "Latex Examination Gloves Powder-Free (Black Color) and with Protein Content Labeling Claim (50 micrograms or less)". It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as a previously cleared device. The "acceptance criteria" in this context would primarily pertain to compliance with FDA regulations, good manufacturing practices, and performance characteristics (like protein content, physical properties such as tensile strength and elongation, and freedom from holes) that demonstrate substantial equivalence to predicate devices, rather than a statistical study proving clinical performance of an AI/ML diagnostic tool.

Therefore, I cannot provide the requested information from the provided text as it is not present in this type of FDA document.

Ask a specific question about this device

Latex Examination Glove Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Latex Examination Gloves Powder Free With Lined.

The provided text describes a 510(k) premarket notification for "Latex Examination Gloves Powder Free With Lined." This submission is for a medical device that does not involve an AI component or complex analytical software. Therefore, the questions related to AI performance, ground truth, expert adjudication, and multi-reader multi-case studies are not applicable.

The document focuses on demonstrating that the gloves meet established industry standards for physical properties and safety.

Here's an analysis of the available information regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The document states that the performance data is "the same as mentioned immediately above," referring to the detailed table of dimensions and physical properties.
• The primary method of demonstrating acceptance is through a certification statement that the gloves meet or exceed the ASTM D 3578-01ae2 Standard and FDA pin hole requirements.

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

The document does not explicitly state the sample sizes used for testing any specific batch or lot of gloves. It refers to the ASTM D 3578-01ae2 Standard for latex examination gloves, which would outline the sampling plan for such tests.

• Sample Size: Not explicitly stated in the provided text.
• Data Provenance: The manufacturer is PT. Shamrock Manufacturing Corp. located in Medan, Indonesia. The testing would have been conducted by them or a contracted laboratory to demonstrate compliance with the ASTM standard. The data is retrospective in the sense that it represents the characteristics of manufactured gloves.

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

This question is not applicable. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM standards) and regulatory requirements (e.g., FDA pinhole requirements). Testing is typically performed according to standardized protocols, and the results are compared against predefined criteria in these standards, not against expert consensus on individual "cases."

4. Adjudication Method for the Test Set

This question is not applicable. As explained above, for physical and chemical testing of gloves, results are typically objective measurements compared against specified quantitative criteria rather than subjective assessments 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

This question is not applicable. The device is a physical medical glove and does not involve AI or human readers for its intended use or evaluation.

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

This question is not applicable. The device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Industry Standards: Specifically, the ASTM D 3578-01ae2 Standard for Latex Examination Gloves. This standard defines the acceptable ranges for dimensions, tensile strength, and elongation, as well as test methods.
• Regulatory Requirements: The FDA pinhole requirement for medical gloves, which specifies an Acceptable Quality Level (AQL) for watertight integrity.
• Labeling Claims: Verification that the product meets its stated specifications, including the protein content claim ("Contains ≤ 50 micrograms or less of total water extractable protein per gram").

8. The Sample Size for the Training Set

This question is not applicable. As this is not an AI/ML device, there is no "training set." The manufacturing process is controlled to consistently produce gloves that meet the specified standards.

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

This question is not applicable, as there is no "training set" for this type of device. The quality control and testing processes ensure that each batch of gloves (or a statistically significant sample from it) meets the established "ground truth" defined by the ASTM standard and FDA regulations.

Ask a specific question about this device

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

Latex Patient Examination Glove, Powdcred Type II, Low Modulus, with extractable protein content labelling claim (200 microgram per gram of glove or less)

This document is a 510(k) clearance letter for "Latex Examination Gloves, Powdered Type II, Low Modulus with Extractable Protein Content Labeling Claim (200 Micrograms or Less)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria, device performance studies, or ground truth establishment typically found in detailed device validation reports.

The provided text focuses on the regulatory clearance process rather than technical performance data. Therefore, I cannot extract the requested information.

Ask a specific question about this device

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

Latex Examination Gloves, Powder Free, Polymer Coated

This is an FDA 510(k) clearance letter for "Latex Examination Gloves, Powder Free, Polymer Coated". This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.

Here's why the requested information cannot be extracted and what the document does provide:

• No Acceptance Criteria or Device Performance Table: The document states that the device is "substantially equivalent" to legally marketed predicate devices. It does not provide specific performance metrics (e.g., tensile strength, puncture resistance, barrier integrity) or the acceptance criteria for those metrics. This level of detail would typically be found in the 510(k) submission itself, not the clearance letter.
• No Study Details (Sample Size, Data Provenance, Ground Truth, Training Set): As this is a clearance letter and not a study report, it does not describe any specific studies conducted by the manufacturer to demonstrate performance. The "substantial equivalence" determination relies on demonstrating that the new device is as safe and effective as a predicate device already on the market, often through comparison of materials, design, and intended use, and sometimes through performance testing if there are significant differences from the predicate. However, the details of such testing, if performed, are not in this letter.
• No Information on Experts, Adjudication, or MRMC Studies: These concepts are typically relevant for AI/ML-based diagnostic devices or complex imaging analysis, where expert interpretation and consensus are crucial for establishing ground truth and evaluating human-AI interaction. This document is for a physical medical device (examination gloves), so these types of studies are not applicable or mentioned.
• Standalone Performance: The concept of "standalone performance" (algorithm only) is not relevant to a physical medical device like gloves.

What the document does tell us:

• Device Name: Latex Examination Gloves, Powder Free, Polymer Coated
• Regulation Number & Product Code: 880.6250, LYY (Patient Examination Gloves)
• Regulatory Class: I (lowest risk class, subject to general controls)
• Indications For Use: A disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Date of Clearance: June 7, 2002
• Type of Clearance: 510(k) Premarket Notification, based on "substantial equivalence" to a predicate device.

To obtain the detailed information requested, one would need to access the original 510(k) submission (K021412), which is usually publicly available through the FDA's databases, although often redacted for proprietary information. That submission would describe the specific tests performed (e.g., physical property testing, biocompatibility, leak testing) and the criteria used to demonstrate that the gloves meet recognized standards and are substantially equivalent to marketed predicate devices.

Ask a specific question about this device

EXAMINATION GLOVES POWDER FREE IS A POWDER FREE LATEX DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND ob eximali contrail contrainer time between batten and EXAMINER.

Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578

The device is a Latex Examination Glove (Powder free) manufactured by Brightway Gloves Pvt. Ltd., intended for medical purposes to prevent contamination between patients and examiners. The acceptance criteria and performance data are detailed below, comparing the device's characteristics against ASTM D3578 requirements.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that the performance test data is for "Latex Examination Glove powder free manufactured by M/S Brightway Gloves Pvt.Ltd." However, the sample size used for these tests is not explicitly stated in the provided document. The data provenance is
retrospective by the manufacturer, Brightway Gloves Pvt. Ltd., located in Tamil Nadu, India.

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 for the physical and performance properties of the gloves is established by the ASTM D3578 standard specifications. No human expert "ground truthing" is mentioned or implied for these types of measurements.

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

Not applicable. This is a measurement of physical and performance characteristics against a standard, not a subjective assessment requiring adjudication among experts.

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 Latex Examination Glove, not an AI or diagnostic medical 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 Latex Examination Glove, not an AI or algorithmic device.

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

The ground truth is based on the ASTM D3578 standard specifications for Latex Examination Gloves. These are established industry standards for the physical and performance characteristics of such gloves.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE MADE OF NATURAL LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER AND IS POWDERED WITH A DONNING POWDER ABSORBABLE USP CORN STARCH.

Class I Patient Examination Gloves (powdered) 80L that meets all 'the requirements of ASTM D3578.

Here's the breakdown of the acceptance criteria and study information for the Latex Examination Gloves (Powdered) from Brightway Gloves Pvt. Ltd., as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For characteristics like Powder Content, Protein Content, Moisture Content, and Biocompatibility, no specific ASTM D3578 numerical requirement was explicitly listed in the tables provided for direct comparison. However, the "Conclusion of Performance Test Data" explicitly states that the gloves "Meet or exceed the ASTM D3578" and "Meet FDA Pin hole Requirement" and "Meet labelling claim," implying that the stated performance values for these attributes align with the relevant standards.

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

The document does not explicitly state the specific sample size used for the test set for each parameter. It lists the measured values for various glove sizes and properties. The data provenance is from India (manufacturer is M/s. BRIGHTWAY GLOVES PVT.LTD. in Tamil Nadu, India). The study appears to be retrospective in the sense that it presents the results of tests already conducted (e.g., "The performance test data... given below").

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

N/A. This is a medical device (patient examination gloves) that is evaluated against established technical standards (ASTM D3578) and regulatory requirements (FDA pinhole requirement). The ground truth is objective measurement data against these standards, not expert interpretation of subjective information.

4. Adjudication Method for the Test Set

N/A. As mentioned above, the determination is based on objective measurements against predefined standards, not subjective assessments requiring adjudication among experts.

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

N/A. This is a physical medical device (gloves), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance.

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

N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for this device is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578 (Standard Specification for Rubber Examination Gloves)
• FDA Pinhole Requirement

These provide objective benchmarks for physical, chemical, and performance properties.

8. The sample size for the training set

N/A. This is a physical medical device. The concept of a "training set" is relevant for AI algorithms, not for the manufacturing and testing of examination gloves. The product undergoes quality control and testing against specifications, not machine learning model training.

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

N/A. As above, the concept of a "training set" and its ground truth establishment is not applicable to this type of device.

Ask a specific question about this device