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510(K) Summary OCT 2 1 2010 - gov fda accessdata www

510(K) Summary OCT 2 1 2010 - gov fda accessdata www-2025

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The document is a 510(k) summary submitted by Tangshan Kangjie Glove Co., Ltd. for their Powder Free Vinyl Patient Examination Gloves, Colored (Yellow). It outlines the device's safety and effectiveness in accordance with FDA regulations, including its intended use as a disposable medical glove to prevent contamination. The summary includes details about the device's classification, predicate devices, technological characteristics, and compliance with relevant ASTM standards. The FDA has determined that the gloves are substantially equivalent to legally marketed devices.

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Click ‘Get Form’ to open the document in the editor.
Begin by entering the submitter's information on the first page. This includes the name, address, phone and fax numbers, contact person, and preparation date.
Fill in the device details such as the proprietary name, common name, classification name, and regulation number. Ensure accuracy for compliance.
Identify the legally marketed device for substantial equivalence. Provide details about the predicate device including its classification and product code.
Describe the device's intended use clearly. Specify that it is a disposable medical device aimed at preventing contamination.
Summarize technological characteristics compared to the predicate device. Include dimensions and performance standards.
Conclude with a discussion of nonclinical and clinical data supporting safety and effectiveness.

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

How long will it take my 510 K to be cleared by the US FDA?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What is the FDA 510k 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 are the three types of 510k?

Overview. A submitter may choose from three types of Premarket Notification 510(k) submissions to seek marketing clearance for their device when appropriate for review under the 510(k) Program: Traditional, Special, and Abbreviated.

What does the FDA do summary?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.

What is the difference between 510k clearance and approval?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

What does FDA granted 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).

How to view 510 k submissions?

Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.

What is the FDA brief summary requirement?

The law requires that print ads making claims about a drug (product claim ads) include a brief summary with all the risks listed in the drugs prescribing information and at least one FDA-approved use of the drug. The brief summary generally includes: Who should not take the drug. When the drug should not be taken.

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