Search Results

An Examination glove is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

POWDERFREE STERILE LATEX EXAMINATION GLOVES

This document is an FDA 510(k) clearance letter for Powder-free Sterile Latex Examination Gloves. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not contain details about specific acceptance criteria or a study proving the device meets those criteria, as typically requested for AI/software device submissions.

The letter confirms general compliance with regulations applicable to Class I devices. The "Indications for Use" section simply defines what an examination glove is and its purpose, rather than establishing performance metrics.

Therefore, I cannot provide the requested information based on the provided text. The document is about regulatory clearance, not performance study results.

Ask a specific question about this device

A Surgeon's glove is a device made of natural nusber intended to be worn by operating room personnel to protect a surgicul wound from concamination.

POWDERFREE LATEX SURGEON'S GLOVES . Cantains 50 megm on less of Total Water per gram protect

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-free Latex Surgeon's Gloves." It focuses on the regulatory approval process and does NOT contain information about acceptance criteria, study details, or device performance against specific metrics as would be typically found in a clinical or performance study report for AI/medical imaging devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text. The document is a regulatory approval letter, not a scientific study report.

The information you've requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth types, training set details) is not present in this type of FDA correspondence.

Ask a specific question about this device

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

STERILE PATIENT EXAMINATION GLOVES - POWDERFD

This document is a 510(k) clearance letter from the FDA for "Sterile Patient Examination Gloves, Powdered." It is not a study report or a document describing the acceptance criteria or performance of a medical device based on a clinical or technical study.

Therefore, most of the requested information cannot be extracted from the provided text. The document primarily serves as an official notification that the device has been deemed "substantially equivalent" to predicate devices and can be marketed.

Here's what can be gathered and what cannot:

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

• Cannot be extracted. This document does not contain acceptance criteria for performance benchmarks, nor does it report specific device performance data. The 510(k) process for patient examination gloves typically relies on adherence to recognized standards (e.g., ASTM standards for physical properties, biocompatibility) rather than complex clinical studies with performance metrics like sensitivity, specificity, or AUC as one might see for diagnostic AI devices. The substantial equivalence determination means it met these standards but the specific acceptance criteria and performance data are not detailed here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be extracted. No test set, sample size, or data provenance is mentioned as this is not a study report.

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)

• Cannot be extracted. This information is irrelevant to a 510(k) clearance for examination gloves.

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

• Cannot be extracted. Not applicable to this type of regulatory document.

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

• Cannot be extracted. This document is for examination gloves, not an AI-powered diagnostic device. MRMC studies are not relevant here.

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

• Cannot be extracted. This document pertains to a physical medical device (gloves), not a software algorithm.

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

• Cannot be extracted. No ground truth defined in this context. Substantial equivalence for gloves typically relies on compliance with material specifications, mechanical properties, and biocompatibility standards.

8. The sample size for the training set

• Cannot be extracted. No training set is involved for this type of device and regulatory submission.

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

• Cannot be extracted. Not applicable.

Summary from the provided document:

The provided text is an FDA 510(k) clearance letter for "Sterile Patient Examination Gloves, Powdered." It confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. The letter explicitly states the device's indications for use: "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."

This document does not contain information about specific performance data, acceptance criteria metrics, sample sizes for studies, expert qualifications, or details typically found in scientific study reports for complex medical devices or AI algorithms.

Ask a specific question about this device

A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination

pre-POWDERED LATEX SURGEON'S GLOVES

This document is a 510(k) clearance letter from the FDA for Sanrea Healthcare Private Limited's "Pre-Powdered Latex Surgeon's Gloves." It does not contain information on acceptance criteria, study data, or AI-related performance. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This document is solely an FDA clearance for marketing the device based on substantial equivalence to a predicate device.

Ask a specific question about this device