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Ask a specific question about this device

Ask a specific question about this device

A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.

A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.

The provided document is a 510(k) clearance letter from the FDA for medical gloves. This type of document declares that a device is substantially equivalent to a predicate device already on the market. It does not contain information about formal acceptance criteria, device performance studies, sample sizes, expert ground truthing, or multi-reader multi-case studies, which are typically found in detailed technical reports or clinical study summaries.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

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A sterile power-free latex surgeon's glove is a disposable device intended for medical purpose that is worn by operating room personnel to protect a surgical wound from contamination.

Sterile Powder-Free Latex Surgical Gloves

Analysis of Device Acceptance Criteria and Study:

The provided documents are a 510(k) clearance letter from the FDA for "Sterile Powder-Free Latex Surgical Gloves" and related forms. This type of FDA clearance relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical studies with specific acceptance criteria in the way a novel AI or diagnostic device would.

Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" are not directly applicable to a 510(k) submission for a Class I medical device like surgical gloves. The "acceptance criteria" here are primarily regulatory and performance standards for gloves, not diagnostic metrics.

However, I can extract information relevant to the intent of your questions based on what is typically required for a 510(k) of this nature.

1. Table of Acceptance Criteria and Reported Device Performance:

For surgical gloves, the primary performance criteria revolve around safety, barrier integrity, and physical properties. These are typically assessed against recognized industry standards (e.g., ASTM, ISO). The 510(k) summary (which is not fully provided here but would be part of the submission) would detail the specific tests conducted and their compliance.

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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 examiners.

Multi-ply Powder-free Latex Examination Gloves with Protein content labeling claim(50ug/g or less total water extratable protein content)

This is a 510(k) premarket notification letter from the FDA regarding "Multi-Ply Powder-Free Latex Examination Gloves With Protein Content Labeling Claim (50ug/g Or Less Total Water Extractable)". It is a regulatory approval document and does not contain the information requested about acceptance criteria, device performance, study details, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates a "substantial equivalence" determination, not a study demonstrating performance against specific acceptance criteria in the way a clinical or AI performance study would.

Therefore, I cannot provide the requested information based on the provided text.

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

Pre-Powdered with USP Absorbable Dusting Powder Latex Examination Glove-Blue Color with Protein Labeling Claims 100mic grams or less)

The provided text is related to a 510(k) premarket notification for "Powdered Latex Examination Gloves, With Protein Content Labeling Claim (100 Micrograms or Less)." This document is an FDA clearance letter and an "Indications for Use" statement. It does NOT contain information about acceptance criteria, efficacy studies, or performance data of an AI/ML powered device.

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

The request asks for specific details about an AI/ML powered device's performance, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

None of this information is present in the provided FDA 510(k) clearance letter for latex examination gloves, which is a traditional medical device, not an AI/ML powered one.

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

Powder-free Latex Examination Glove with Labeling Claim of 50 micrograms or less of total water extractable protein per gram.

This document is a FDA 510(k) clearance letter for a "Powder-Free Latex Examination Glove With Labeling Claim of 50 micrograms or less of total extractable protein per gram." It does NOT contain information regarding a study proving acceptance criteria for a device involving AI or complex performance metrics.

The letter simply states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for Class I medical devices based on its intended use and safety profile.

Therefore, I cannot provide the requested information as it is not present in the provided text. The criteria for "substantial equivalence" for this type of device are primarily related to material composition, manufacturing practices, and safety for its intended use (preventing contamination between patient and examiner), rather than complex performance metrics that would require the detailed studies outlined in your request.

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