Get the 510(k) Summary for Powder Free Nitrile Examination Gloves - accessdata fda

This document summarizes safety and effectiveness information for the Powder Free Nitrile Examination Gloves intended for use with chemotherapy drugs, submitted to comply with FDA regulations.

How to fill out 510k summary for powder

How to fill out 510(k) Summary for Powder Free Nitrile Examination Gloves

1. Begin by identifying the device: Clearly state that you are submitting a 510(k) for Powder Free Nitrile Examination Gloves.
2. Provide the applicant details: Include the name, address, and contact information of the manufacturer or applicant.
3. Identify the predicate device: Reference a similar legally marketed device that your gloves are equivalent to, including the 510(k) number.
4. Describe the device: Give a detailed description of the gloves, including materials, dimensions, and design.
5. Outline the intended use: Specify the medical purposes for which the gloves are intended.
6. Detail the technological characteristics: Explain how your gloves compare technologically to the predicate device, focusing on material composition, performance, and design features.
7. Summarize performance testing: Include results of biocompatibility, physical properties, and any other relevant testing that demonstrates compliance with FDA standards.
8. Provide labeling information: Include proposed labels, instructions for use, and promotional materials if applicable.
9. Complete the 510(k) summary: Ensure all sections are filled out accurately and clearly to aid in FDA review.
10. Submit your 510(k): Follow the regulations for submission and ensure all required documents, forms, and fees are included.

Who needs 510(k) Summary for Powder Free Nitrile Examination Gloves?

1. Manufacturers of Powder Free Nitrile Examination Gloves who want to market their products in the United States.
2. Companies looking to demonstrate that their gloves are substantially equivalent to a predicate device already approved by the FDA.
3. Healthcare providers and users requiring assurance that the gloves meet safety and effectiveness standards.

People Also Ask about

What is 510k clearance for medical devices?

The 510k clearance process is the most common pre-market pathway used by medical device companies to legally sell products in the US, as data from the FDA shows that: 35% of medical devices are in Class I, the lowest risk class, as they present minimal potential for harm to the end user.

What does powder-free nitrile gloves mean?

Powder-free gloves do not contain cornstarch. To make them easy to put on and remove, these gloves go through chlorination; a process that makes them less form-fitting. This extra step used to make nitrile gloves significantly more expensive than latex.

What does 510k clearance mean?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

Is 510k the same as FDA approval?

A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same level of risks, a CE Mark is required to market a medical device in the European Economic area.

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What is 510(k) Summary for Powder Free Nitrile Examination Gloves?

A 510(k) Summary is a document submitted to the FDA by manufacturers of medical devices, including powder free nitrile examination gloves, to demonstrate that their product is safe and effective and substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary for Powder Free Nitrile Examination Gloves?

Manufacturers or importers of powder free nitrile examination gloves that intend to market the product in the United States must file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary for Powder Free Nitrile Examination Gloves?

To fill out a 510(k) Summary, manufacturers must provide specific information about the device, including its intended use, description, performance testing, labeling, and any substantial equivalence claims to other marketed devices.

What is the purpose of 510(k) Summary for Powder Free Nitrile Examination Gloves?

The purpose of the 510(k) Summary is to inform the FDA and the public that the device meets safety and effectiveness standards and that it is substantially equivalent to a previously cleared device.

What information must be reported on 510(k) Summary for Powder Free Nitrile Examination Gloves?

The 510(k) Summary must report the device's name, identification, classification, intended use, description, technological characteristics, performance data, labeling information, and details of the predicate device it is claiming equivalence to.