Search Results

POWDERED LATEX EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALITE CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELLING (100 MICROGRAM OR LESS)

This document is a 510(k) clearance letter from the FDA for "Powdered Latex Examination Gloves W/Protein Trade Name: Labeling (100 Micrograms or Less Per Gram)". This type of regulatory submission is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device.

The information provided does not contain details about specific acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic or AI-powered device.

Instead, the letter indicates that the device has been found substantially equivalent to predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, they do not raise different questions of safety and effectiveness.

Here's what can be inferred from the document regarding the device and its regulatory status, and why it doesn't provide the requested information:

• Device Type: Powdered Latex Examination Gloves with Protein Labeling (100 Micrograms or Less)
• Regulatory Class: I (General Controls)
• Product Code: LYY
• Intended Use: "POWDERED LATEX EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT."

Why the requested information is absent:

The questions you've asked (about acceptance criteria tables, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are typically associated with the evaluation of diagnostic devices, AI/ML-driven software, or devices with measurable performance outcomes that require clinical validation studies to demonstrate safety and effectiveness.

For a Class I device like examination gloves, the "acceptance criteria" for 510(k) clearance primarily revolve around demonstrating substantial equivalence to a predicate device. This usually involves:

1. Same Intended Use: As stated in the document.
2. Similar Technological Characteristics: This would involve comparing material, design, manufacturing processes, and performance specifications (e.g., tensile strength, barrier integrity, protein content for label claims) to a predicate device.
3. Meeting Recognized Standards: Often, these devices must meet specific ASTM or ISO standards for medical gloves (e.g., ASTM D3578 for medical examination gloves).
4. Labeling: The label claims, particularly regarding protein content (100 micrograms or less per gram), are a key aspect and would need to be supported by testing.

The "study that proves the device meets the acceptance criteria" for a glove would likely be a series of non-clinical bench tests (e.g., integrity testing, physical properties testing, protein content assays) showing compliance with relevant standards and the advertised protein level, rather than clinical trials with human subjects or expert consensus.

Therefore, I cannot provide the requested table and detailed study information because this document (a 510(k) clearance letter for examination gloves) does not contain that type of data. It confirms regulatory clearance based on substantial equivalence, but not the specific performance metrics and validation study details you'd find for more complex diagnostic or AI-enabled devices.

Ask a specific question about this device