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.

Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove, with extractable protein content labeling claim (50 microgram per gram of glove or less)

This document is a 510(k) premarket notification clearance letter for a medical device, specifically a "Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove." The letter indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

However, this type of document (a 510(k) clearance letter) does not typically contain detailed information about acceptance criteria or specific study results in the way you've requested for performance validation. Instead, it confirms that the manufacturer has submitted sufficient information to demonstrate substantial equivalence to a predicate device, often based on adherence to recognized standards and general safety/performance considerations.

Therefore, I cannot extract the specific information you are asking for (acceptance criteria table, sample sizes for test/training, expert details, adjudication methods, MRMC study results, standalone performance, or detailed ground truth methods) directly from this document. These details would typically be found in the submission's technical documentation, test reports, or clinical study summaries, which are not part of this clearance letter.

The clearance letter focuses on:

• Device Name: Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove with Extractable Protein Content Labeling Claim (50 Microgram per gram of Glove of Less)
• Regulation Number/Name: 21 CFR 880.6250, Patient Examination Glove, Class I
• Indication for Use: A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Key Claim: "extractable protein content labeling claim (50 microgram per gram of glove or less)" - this implies a specific performance characteristic related to latex protein content, which is often a key criterion for latex gloves.

To answer your questions, one would need access to the actual 510(k) submission and its supporting documentation, not just the FDA's clearance letter.

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.

Polymer-Coated, Powder-free, Latcx Patient Examination Glove with Protein Labelling Claim (contain 50 microgram or less of total water extractable protein per gram)

There is no information about the acceptance criteria or a study proving device performance in the provided text. The document is an FDA 510(k) clearance letter for "Polymer Coated, Powder-Free Latex Examination Gloves."

This letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory requirements and classification but does not contain details about specific performance metrics, clinical studies, or an AI device.

Therefore, I cannot provide answers to the requested points, as they are not present in the given document.

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.

Chlorinated, Polymer-Coated, Powder-free, Latex Patient Examination Glove

This document is a 510(k) clearance letter from the FDA for a Chlorinated, Polymer-Coated, Powder-Free Latex Examination Glove. It is a regulatory approval document and does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to the prompt's request for AI/device performance studies.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data or study methodologies.

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.

Chlorinated, Polymer-Coated , Powder-free , Latex Patient Examination Glove

The provided text is a 510(k) premarket notification letter from the FDA regarding a Chlorinated, Polymer-Coated, Powder-Free Latex Examination Glove. This document approves the device for marketing based on its substantial equivalence to legally marketed predicate devices.

The information you are requesting about acceptance criteria and study details (such as sample size, ground truth, expert qualifications, adjudication methods, and MRMC studies) is typically found in the device's 510(k) summary or a more detailed submission document, not in the approval letter itself. The approval letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent, implying that the submitted data met the necessary criteria for equivalence.

Therefore,based on the provided document, I cannot fulfill your request for the following reasons:

1. No Acceptance Criteria or Performance Data: The letter does not specify any quantitative acceptance criteria or report device performance metrics (e.g., sensitivity, specificity, accuracy, or physical property measurements like tensile strength, elongation, or barrier integrity for a glove). It states that the device is "substantially equivalent," which means it performs as safely and effectively as a predicate device, but the specific metrics used for that determination are not detailed here.

2. No Study Details: The letter does not include information about:

   • Sample sizes used for testing.
   • Data provenance (country of origin, retrospective/prospective).
   • Number or qualifications of experts.
   • Adjudication methods.
   • MRMC comparative effectiveness studies.
   • Standalone algorithm performance (this device is a physical medical glove, not an AI algorithm).
   • Type of ground truth used.
   • Training set sample size or how its ground truth was established.

In summary, the provided document is an FDA approval letter for a medical glove, not a detailed technical report or study summary. Therefore, it does not contain the information requested about acceptance criteria and study specifics.

To obtain this information, one would typically need to consult the full 510(k) submission document or summary, which may be available through the FDA's public databases.

Ask a specific question about this device