Search Results

A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Syntex Powder-Free Latex Examination Gloves - Blue Color. A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder.

The provided text is a scanned FDA 510(k) clearance letter for "Syntex Powder-Free Latex Examination Gloves". This document pertains to the regulatory clearance of a medical device based on substantial equivalence to a predicate device, rather than a study proving performance against specific acceptance criteria.

The letter explicitly 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..."

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or information about training sets for an AI/algorithm-based device.

The questions are designed for a scenario where an AI or algorithm-based device undergoes performance evaluation and validation, which is not the subject of this 510(k) clearance for a physical medical product like examination gloves.

Ask a specific question about this device

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Syntex Powder-Free Latex Examination Glove

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) premarket notification letter from the FDA to Syntex Healthcare Product Company Limited regarding their "Syntex Powder-Free Latex Examination Glove".

This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device and can be marketed. However, it does not include details about:

1. Acceptance criteria: There is no table of specific performance metrics or a detailed description of what constitutes "acceptance."
2. Reported device performance: The letter does not contain any test results, data, or performance statistics for the Syntex glove.
3. Study details: There is no mention of a specific study, its design, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either training or test sets.

The letter primarily focuses on the regulatory decision of substantial equivalence and general compliance requirements. To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSD), a clinical study report, or a more detailed 510(k) submission document that typically includes performance data.

Ask a specific question about this device

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Powder-Free Latex Examination Glove with Protein Labeling Claim ( 50 Micrograms or Less )

This document is a 510(k) clearance letter from the FDA for a Powder-Free Latex Examination Glove with Protein Labeling Claim (50 Micrograms or Less).

Unfortunately, this type of document is not relevant to the request of describing acceptance criteria and a study proving a device meets those criteria for an AI/ML medical device.

Here's why:

• Device Type: This document pertains to a physical medical device (examination gloves), not an AI/ML software device.
• Regulatory Pathway: The 510(k) pathway for traditional medical devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through performance testing on physical attributes (e.g., tensile strength, barrier integrity, protein content for allergies). It does not typically involve the kinds of clinical performance studies (e.g., diagnostic accuracy, sensitivity, specificity) that are foundational to AI/ML device evaluations.
• Missing Information: The letter itself only confirms the clearance and does not detail the specific test methods, acceptance criteria, or study designs used to support the substantial equivalence claim for the glove. It references a "Protein Labeling Claim," implying tests were done for protein content, but no specifics are provided.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document as it simply isn't present or relevant to an AI/ML context.

To provide the requested information, I would need a document that describes the clinical validation or performance study for an AI/ML-based medical device.

Ask a specific question about this device