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"An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner." In addition, the glove is suitable for oncology use.

Powder-Free Natural Rubber Latex Examination Glove (Tested For Use With Chemotherapy Drugs) With Protein Content Labeling Claim (50 micrograms or less)

This document is a marketing approval letter for a medical device (a glove), not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study design, and performance metrics cannot be extracted.

The document states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates that the device meets the regulatory requirements for marketing, but it does not provide specific performance criteria or the results of a scientific study as you would expect for evaluating an AI medical device.

Specifically, none of the requested information (points 1-9) can be found in the provided text. The document pertains to regulatory approval based on substantial equivalence, not a clinical or technical performance study.

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

Non-Sterile, Powderfree Nitrile Patient Examination Glove

I am sorry, but the provided text from the FDA letter does not contain information about the acceptance criteria or a study that proves a device meets such criteria. The letter is a 510(k) clearance for "Skinsense Nitrile Powder-Free Synthetic Medical Examination Gloves," indicating that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.

The document discusses:

• The device being cleared for marketing.
• Regulatory classifications and general controls provisions.
• Contact information for various FDA offices.
• The intended use of the examination gloves: "An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner."

There is no mention of specific performance metrics, acceptance criteria, study design, sample sizes, expert qualifications, or comparative effectiveness studies in this document.

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A Sterile surgeon's Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures.

Sterile Indicator Inner Surgeon's Glove

The provided text is a 510(k) clearance letter for a medical device (Regent Biogel Indicator Inner Surgical Glove). It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

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A Sterile surgeon's Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures.

Sterile Orthopediig,Surgeon's Glove WITH PROTENT UNEUNG CLAIM (50 MICROGRAMS or LESS)

The provided text is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about acceptance criteria or a study proving that a device meets those criteria, as typically found in a clinical study report or a detailed pre-market submission.

Therefore, I cannot provide the requested information. The document is strictly a regulatory clearance for a "Regent Biogel Powder-Free Orthopedic Latex Surgical Glove, with Protein Content Labeling Claim (50 Micrograms or Less)," confirming its substantial equivalence to previously marketed devices.

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An 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.

Non-sterile examination glove

This document is a 510(k) clearance letter from the FDA for a medical device: "Regent Biogel Diagnostic Powder-Free Examination Glove with Protein Content Labeling Claim of 50 Micrograms or less".

This type of device (an examination glove) does not typically have acceptance criteria and a study to prove performance in the same way that a diagnostic algorithm or a complex medical instrument would. The clearance is based on substantial equivalence to predicate devices, and the "acceptance criteria" here relate to meeting regulatory standards and the specific protein content claim.

Therefore, many of the requested fields are not applicable to this document. I will fill in what can be inferred or directly stated.

Acceptance Criteria and Device Performance Study for Regent Biogel Diagnostic Powder-Free Examination Glove

1. Table of Acceptance Criteria and Reported Device Performance

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 this 510(k) clearance letter. This document does not detail specific performance studies with test sets in the context of diagnostic or algorithmic performance. The clearance is based on substantial equivalence and regulatory compliance.

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. This device is not evaluated by experts for "ground truth" in the diagnostic sense. The FDA's evaluation is by regulatory experts.

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. This is not an AI-assisted device or a diagnostic device involving human readers.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this type of device is primarily based on:

• Regulatory Standards Compliance: Adherence to established FDA regulations (e.g., general controls, Quality System Regulation).
• Performance Benchmarking to Predicate Devices: Demonstrating that the device is as safe and effective as a legally marketed predicate device (which would have its own established performance characteristics, often related to physical properties like tensile strength, barrier integrity, and protein content).
• Manufacturer's Internal Testing: The manufacturer would have conducted tests to substantiate the protein content claim and other performance characteristics, which are reviewed by the FDA during the 510(k) process, but the detailed results are not in this letter.

8. The sample size for the training set

Not applicable. This is not a machine learning or diagnostic device that uses a "training set."

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

Not applicable.

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