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This document summarizes the 510(k) premarket notification for the Senstouch Nitrite Examination Gloves, detailing their intended use, technological characteristics, performance testing, and equivalence

How to fill out 510k summary for nitrile

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

1. Identify the device: Clearly state that the submission is for Nitrile Examination Gloves.
2. Provide the submitter information: Include the name, address, and contact details of the manufacturer.
3. Describe the device: Include the intended use, design, materials, and specifications of the Nitrile Examination Gloves.
4. Indicate the classification: State the appropriate FDA classification and regulatory information.
5. Summarize the substantial equivalence: Compare the Nitrile Examination Gloves to the predicate device, highlighting similarities and differences.
6. Include performance testing: Provide data on testing for safety, effectiveness, and durability, if applicable.
7. Document any labeling: Include copies of the proposed labeling and instructions for use.
8. Include additional data: Attach any clinical or non-clinical studies, if relevant.
9. Review and format: Ensure the entire summary is clear, concise, and complies with FDA requirements before submission.

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

1. Manufacturers of Nitrile Examination Gloves intending to market their products in the U.S.
2. Companies seeking FDA clearance for their gloves to ensure they meet safety and effectiveness standards.
3. Distributors and suppliers needing regulatory compliance for their product offerings.

People Also Ask about

Why do some gloves say not for medical use?

If more than 2.5 out of 100 are defective, the batch doesn't qualify as medical-grade. Surgical gloves, however, require an AQL of 1.5 or lower. In the cases of AQLs higher than 2.5, gloves are often marketed and sold as industrial-grade gloves instead. Industrial or general-purpose gloves may have an AQL as high as 4.

Can you use nitrile gloves for medical use?

If you are or your patient is allergic to natural rubber latex, you should choose medical gloves made from other synthetic materials (such as polyvinyl chloride (PVC), nitrile, or polyurethane). Be aware that sharp objects can puncture medical gloves. Always change your medical gloves if they rip or tear.

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 difference between medical and non-medical nitrile gloves?

The difference is that the Quality Control and Quality Assurance testing levels are more stringent for Medical Exam Grade gloves. The AQL, or Acceptable Quality Limit, for Medical Exam Gloves (Class One Medical Devices) must be 2.5 or lower.

What is the HS Code for nitrile examination gloves?

Nitrile Gloves Import Data under HS Code 40151900 with Price.

Are there different grades of nitrile gloves?

Thicker grade nitrile will last longer and provide better protection when handling chemicals and fluids. Whilst the thicker re-usable industrial nitrile glove will provide a longer contact time resistance, the thinner gloves generally provide more dexterity for the user making more intricate tasks easier to perform.

Are all nitrile gloves medical grade?

Not all nitrile gloves are medical grade. Nitrile gloves are medical-grade only if they meet the required strength levels to protect users against blood-borne pathogens. Nitrile gloves for healthcare applications must have an Acceptable Quality Level (AQL) of 2.5 or less for FDA approval.

For pdfFiller’s FAQs

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

The 510(k) Summary for Nitrile Examination Gloves is a premarket submission made to the FDA to demonstrate that the gloves are as safe and effective as a legally marketed predicate device.

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

Manufacturers of Nitrile Examination Gloves that wish to market their products in the United States must file a 510(k) Summary with the FDA.

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

To fill out a 510(k) Summary for Nitrile Examination Gloves, manufacturers should provide information including device description, intended use, comparison to predicate devices, and performance testing data.

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

The purpose of the 510(k) Summary is to demonstrate that the Nitrile Examination Gloves are substantially equivalent to existing devices, ensuring safety and efficacy for medical use.

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

The 510(k) Summary must report details such as device name, classification, intended use, material composition, performance data, labeling information, and any clinical studies conducted.