Search Results

A powder-free 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.

The Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.

The provided documents describe the performance testing of "BPG Latex Examination Gloves" (Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile) to demonstrate substantial equivalence for a 510(k) submission.

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

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

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

• The documents do not explicitly state the sample sizes used for the individual tests (e.g., how many gloves were tested for pinholes, or how many rabbits were used for biocompatibility testing).
• The data provenance is retrospective, as these are reports generated to demonstrate compliance with existing standards. The country of origin for the data is implied to be Malaysia, where the submitter, Best Putra Gloves Sdn Bhd, is located.

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 in this context. For medical devices like examination gloves, the "ground truth" is established by adherence to recognized national and international standards (e.g., ASTM standards, FDA regulations). Performance is measured objectively against these established criteria, not by expert consensus on specific cases, which is more typical for diagnostic AI devices.

4. Adjudication method for the test set:

• This question is not applicable. As explained above, the assessment is against objective, predefined standards, not through an adjudication process involving human experts for discrete "cases."

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 medical glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI-related effect sizes are irrelevant to its 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. Performance tests directly measure the physical and chemical properties of the glove.

7. The type of ground truth used:

• The ground truth used is based on established industry standards and regulatory requirements. Specifically, this includes:
  • ASTM (American Society for Testing and Materials) standards (e.g., D 3578-01a2, D 6124-05, D 5712-99) for dimensions, physical properties, pinhole freedom, powder amount, and water-soluble protein content.
  • FDA regulations (e.g., CFR 800.20 for pinholes, and the FDA 1000 ml Water Leak Test).
  • Standard biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Dermal Sensitization).

8. The sample size for the training set:

• This question is not applicable. Medical gloves are not typically "trained" in the way an AI model is. The product is manufactured and then tested for compliance with specifications. There isn't a "training set" in the machine learning sense. The manufacturing process itself is continuously monitored to ensure quality.

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

• This question is not applicable for the same reasons as point 8. The "ground truth" for glove manufacturing would be the established manufacturing specifications and quality control parameters derived from the standards mentioned above.

Ask a specific question about this device

A powdered 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.

The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.

This document describes the technical characteristics and performance of "Powdered, Natural Color, Latex Examination Gloves, Non-Sterile" produced by Best Putra Gloves Sdn Bhd. It serves as a 510(k) summary for clearance by the FDA.

1. Acceptance Criteria and Reported Device Performance

The device is assessed against ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test. The table below outlines the specific characteristics and their performance:

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 in the "Device Performance" section. However, it indicates that the tests were performed on the device itself. The provenance of the data is not specified in terms of country of origin or whether it's retrospective or prospective. Given the context of a 510(k) submission, these tests would typically be performed prospectively by the manufacturer or a contracted lab.

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

This information is not applicable. The "ground truth" for this device, which refers to ideal design parameters and performance, is established by recognized consensus standards (ASTM D 3578-01a22) and regulatory requirements (FDA 1000 ml Water Leak Test and FDA CFR 800.20 for pinholes), not by expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in clinical studies where expert review is needed for ambiguous cases. In this case, device performance is objectively measured against predefined quantitative and qualitative standards.

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

No MRMC comparative effectiveness study was done. This type of study is not relevant for the type of device (examination gloves) or the nature of its evaluation, which focuses on material properties, physical dimensions, and barrier integrity rather than diagnostic interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This information is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply.

7. Type of Ground Truth Used

The ground truth used for evaluating this device's performance is derived from established industry standards and regulatory requirements. Specifically, this includes:

• ASTM standard D 3578-01a22: This standard specifies the requirements for latex examination gloves, covering dimensions, physical properties, and freedom from pinholes.
• FDA 1000 ml Water Leak Test: A regulatory requirement for assessing the integrity and barrier performance of gloves against pinholes.
• FDA CFR 800.20: Regulations pertaining to medical devices, specifically for pinholes in gloves.
• D 6124 - 05: Standard test method for assessing powder on medical gloves.
• D 5712-99: Standard test method for the analysis of protein in natural rubber and its products.
• Biocompatibility tests: These tests (Primary Skin Irritation in Rabbits, Dermal Sensitization) are standard toxicological assessments to ensure the material does not cause adverse biological reactions.

8. Sample Size for the Training Set

This information is not applicable. The concept of a "training set" belongs to machine learning and AI development, which are not relevant to the evaluation of this physical medical device.

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 device evaluation.

Ask a specific question about this device

A BPG powdered latex surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This excludes the lubricating or dusting powder used in the glove.

Powdered, Latex Surgical Glove

This document is an FDA 510(k) clearance letter for a Powdered Latex Surgical Glove. It is a regulatory approval document and does not contain any information about a study or acceptance criteria related to a medical AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, or MRMC comparative effectiveness studies because this document pertains to a physical medical device (surgical gloves), not an AI/ML system.

Ask a specific question about this device

A BPG powder-free latex surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Powder-Free, Latex Surgical Glove

This document is a 510(k) premarket notification letter from the FDA to Best Putra Gloves SDN. BHD. regarding their Powder-Free Latex Surgical Glove. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document is an FDA clearance letter for a medical device (a surgical glove), not a study report for an AI/ML medical device.

Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth is present in this document because it is not applicable to a traditional medical device 510(k) clearance in the way you've framed your questions for an AI/ML medical device.

To directly answer your numbered points based only on the provided text, and highlighting its irrelevance to your specific questions:

1. A table of acceptance criteria and the reported device performance: This document does not contain a table of acceptance criteria or reported device performance in the context of an AI/ML medical device. For a surgical glove, performance criteria would typically involve barrier integrity (e.g., AQL for pinholes), physical properties (tensile strength, elongation), and biocompatibility, which are not detailed here. The letter only states that the device is "substantially equivalent."
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable and not mentioned. This document does not describe a test set or data provenance for an AI/ML algorithm.
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 and not mentioned. The concept of "ground truth" established by experts for a test set is not relevant to a surgical glove's substantial equivalence determination.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned. Adjudication methods are used in studies involving human interpretation or labeling, which is not the case for a surgical glove.
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 and not mentioned. This type of study is specific to AI-assisted diagnostic tools, not surgical gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not mentioned. There is no algorithm involved with a surgical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device like a surgical glove relates to its physical and material properties meeting regulatory standards and predicate device characteristics, not to a diagnostic outcome.
8. The sample size for the training set: Not applicable and not mentioned. There is no training set for a physical surgical glove.
9. How the ground truth for the training set was established: Not applicable and not mentioned. There is no training set for a physical surgical glove.

In summary, the provided document is a regulatory clearance for a physical medical device (surgical glove) and does not contain the information requested, which is tailored for an AI/ML medical device study.

Ask a specific question about this device