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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:

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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:

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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.

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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.

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