Get the free 510(k) Summary for Powdered Vinyl Patient Examination Gloves - accessdata fda

This document provides a summary of the premarket notification for a medical device, specifically the Powdered Vinyl Patient Examination Gloves, including device specifications, intended use, and

How to fill out 510k summary for powdered

How to fill out 510(k) Summary for Powdered Vinyl Patient Examination Gloves

1. Gather all necessary information about the powdered vinyl patient examination gloves.
2. Identify the intended use of the gloves and the specific indications for use.
3. List the regulatory classification and provide the applicable product code.
4. Summarize the device description, including material composition, design, and manufacturing processes.
5. Provide performance data, including any testing results relevant to the device's safety and effectiveness.
6. Include a comparison table that details how your device is equivalent to a predicate device.
7. Address biocompatibility testing results, if applicable.
8. Include labeling information and instructions for use.
9. Submit the 510(k) Summary electronically through the FDA's submission portal.

Who needs 510(k) Summary for Powdered Vinyl Patient Examination Gloves?

1. Manufacturers who are seeking FDA clearance to market powdered vinyl patient examination gloves.
2. Importers of powdered vinyl patient examination gloves who wish to ensure compliance with FDA regulations.
3. Healthcare facilities that want to understand the regulatory status of the gloves they use.

People Also Ask about

What is Section 501 of the Food, Drug and Cosmetic Act?

Section 501(a)(2)(B) of the FD&C Act stipulates that a drug is considered adulterated (poorer in quality by adding another substance) if “the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with

What is the 510k FDA summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is the Section 510 K of the Federal Food Drug and Cosmetic Act?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What does it mean to be 510 K exempt?

A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device (see sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic (FD&C) Act).

What is Food, Drug and Cosmetic Act Section 510 K?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What does FDA 510 K clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

For pdfFiller’s FAQs

What is 510(k) Summary for Powdered Vinyl Patient Examination Gloves?

A 510(k) Summary is a document submitted to the FDA that demonstrates that the powdered vinyl patient examination gloves are safe and effective, and substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary for Powdered Vinyl Patient Examination Gloves?

Manufacturers or importers of powdered vinyl patient examination gloves are required to file a 510(k) Summary before marketing their product in the United States.

How to fill out 510(k) Summary for Powdered Vinyl Patient Examination Gloves?

To fill out the 510(k) Summary, the manufacturer must provide information including the device's intended use, descriptions of the product, labeling, performance data, and comparison with predicate devices.

What is the purpose of 510(k) Summary for Powdered Vinyl Patient Examination Gloves?

The purpose of the 510(k) Summary is to inform the FDA and the public about the safety and effectiveness of the powdered vinyl patient examination gloves and to establish their substantial equivalence to existing products.

What information must be reported on 510(k) Summary for Powdered Vinyl Patient Examination Gloves?

The 510(k) Summary must report information including the device name, intended use, description, labeling, manufacturing information, performance testing results, and any additional supporting data.