Search Results

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDERED VINYL EXAM GLOVES

This document is a 510(k) premarket notification letter for Disposable Powdered Vinyl Exam Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a regulatory clearance letter, not a performance study report. Therefore, I cannot extract the requested information.

Ask a specific question about this device

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is an FDA 510(k) clearance letter for "Disposable Powder Free Vinyl Exam Gloves," dated August 14, 2003.

This type of document primarily confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to a legally marketed predicate device. It certifies that the device can proceed to market under general controls.

The letter does not contain:

• Specific acceptance criteria (such as performance metrics like tensile strength, elongation, or barrier integrity). While such criteria would have been part of the manufacturer's submission, they are not detailed in this clearance letter.
• Details of the study or tests performed by Symertex Company Limited to demonstrate compliance with performance standards. The FDA's review in a 510(k) typically relies on the manufacturer's data demonstrating that their device meets recognized standards or is substantially equivalent to a predicate.
• Information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies. These are typically associated with more complex medical devices that involve diagnostic or therapeutic algorithms, not examination gloves.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This statement clearly indicates the basis for clearance is substantial equivalence to a predicate, not necessarily detailed performance study results within this letter itself.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR

The provided text is a 510(k) summary letter from the FDA to Synmertex Company Limited regarding their Disposable Powder Free Vinyl Synthetic Examination Gloves. This letter does not describe acceptance criteria for a device, nor does it detail a study proving device performance based on such criteria. Instead, it is an FDA clearance letter, indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information from the given text.

The document discusses:

• Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color
• Regulation Number & Product Code: 880.6250, LYZ (Patient Examination Glove, Class I)
• Indications For Use: "A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner."
• FDA Clearance: The letter states the device is "substantially equivalent" to predicate devices.

This type of FDA letter confirms market clearance, but it does not include detailed performance studies, acceptance criteria, or ground truth methodologies that would be typical for many medical devices, especially those involving AI or more complex functionalities. For examination gloves, performance is usually assessed against established ASTM (American Society for Testing and Materials) standards (e.g., for barrier integrity, tensile strength), but these details are not present in this FDA clearance letter.

Ask a specific question about this device

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES

This document is a 510(k) clearance letter from the FDA for "Disposable Powder Free Vinyl Synthetic Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, none of the requested information about acceptance criteria and study details is available. This document is a regulatory approval letter, not a scientific study report. It states that the device is "substantially equivalent" to predicate devices, which implies that it meets recognized standards for examination gloves, but it does not detail specific performance criteria or a study conducted by the manufacturer to prove those criteria.

Therefore, I cannot populate the table or answer questions 2 through 9.

Ask a specific question about this device

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES

The provided documents are a 510(k) premarket notification letter for "Disposable Powdered Vinyl Synthetic Examination Gloves" and an "Indications For Use" statement.

These documents do not contain any information regarding acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic devices. They pertain to a Class I medical device (patient examination glove) which typically undergoes physical and chemical testing rather than clinical performance studies in the way an AI/ML device would.

Therefore, I cannot provide the requested information based on the input text. The information requested (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) is relevant for AI/ML or diagnostic device submissions, not for the type of device described in these documents.

Ask a specific question about this device