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

Sterile Powder Free Latex Surgical Gloves with Protein Labeling Claim ( 50 micrograms or less )

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the device. The document is an FDA 510(k) clearance letter for "Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (50 Micrograms or Less)," confirming its substantial equivalence to a predicate device.

The document includes:

• Trade/Device Name: Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (50 Micrograms or Less)
• Regulation Number/Name: 878.4460 / Patient Examination Gloves
• Regulatory Class: I
• Product Code: KGO
• Indications For Use: A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

It confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table and information about the study.

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

Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim ( 200 Micrograms or Less )

This document is a letter from the FDA regarding a 510(k) premarket notification for "Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (200 Micrograms or Less)."

It is important to understand that a 510(k) notification is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with the detail you've requested for AI/software devices.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment will not be found in this document. This document focuses on the regulatory clearance process for a physical medical device (gloves), not a software or AI-driven diagnostic tool.

Information that CANNOT be Extracted from the Provided Document:

• A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics beyond the protein labeling claim.
• Sample size used for the test set and the data provenance: Not applicable to this type of device clearance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• The type of ground truth used: Not applicable in the context of AI/software ground truth.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that CAN be Extracted (and interpreted in the context of a 510(k) physical device):

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

While not structured as a typical "acceptance criteria" table for an AI study, the core claim being reviewed for this device is the "Protein Labeling Claim (200 micrograms or less)." The FDA's issuance of the 510(k) implies that the manufacturer provided sufficient data (likely through testing following recognized standards for surgical gloves) to substantiate this claim and demonstrate substantial equivalence to a predicate device.

Summary of "Study" (as implied by a 510(k) for this device):

The "study" for a 510(k) for a physical device like surgical gloves typically involves:

• Material Characterization: Demonstrating the material properties of the gloves meet relevant standards (e.g., ASTM, ISO) for strength, elasticity, freedom from holes, etc.
• Sterility Testing: Validating the sterilization process to ensure the gloves are sterile.
• Biocompatibility Testing: Ensuring the materials are safe for skin contact, often through tests like cytotoxicity, sensitization, and irritation.
• Protein Content Testing: Specific analytical testing methods (e.g., modified Lowry method, ELISA) to quantify the amount of extractable protein to substantiate the "200 micrograms or less" claim.
• Shelf-life Testing: Stability studies to ensure the device maintains its properties over its declared shelf life.

The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing it meets recognized consensus standards (like ASTM D3577 for surgical gloves) and has the same technological characteristics and intended use, or that any differences do not raise new questions of safety or effectiveness. The document states a "protein labeling claim" of 200 micrograms or less, which would have been substantiated by specific testing.

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A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE WORN QU THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN THE HEALTH CARE PERSONNEL AND THE PATIENT.

Kleenhands Powdered Latex Examination Gloves

The provided text is a letter from the FDA regarding the clearance of "Kleenhands Powdered Latex Examination Gloves" and an "Indications for Use" statement. It approves the marketing of the device but does not contain acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data or studies.

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A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

Kleenhands Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)

The provided text is a 510(k) premarket notification letter from the FDA regarding "Kleenhands Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)".

This document is a regulatory approval letter, not a scientific study report. Therefore, it does not contain the kind of information requested in your prompt regarding acceptance criteria and a study proving a device meets them.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on ground truth types or how ground truth was established for training or test sets.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device (the gloves) is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. The "Indications For Use" section on page 2 defines what the gloves are for ("A medical or a patient examination glove is a disposable device worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.") and mentions a "PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)", which is a characteristic of the product, but not an acceptance criterion in the context of a performance study.

To answer your prompt, you would need a different type of document, such as a clinical study report or a technical performance evaluation report for an AI/CAD diagnostic device.

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