GONGDONG DISPOSABLE SHARP CONTAINER

K082042 · Zhejiang Gongdong Medical Plastic Factory · MMK · Sep 3, 2008 · General Hospital

Device Facts

• Record ID: K082042
• Device Name: GONGDONG DISPOSABLE SHARP CONTAINER
• Applicant: Zhejiang Gongdong Medical Plastic Factory
• Product Code: MMK · General Hospital
• Decision Date: Sep 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Gongdong Disposable Sharps Container is intended to be used in the healthcare facilities for the safe disposal of hazardous sharps.

Device Story

Gongdong Disposable Sharps Container is a receptacle designed for safe disposal of hazardous sharps in healthcare facilities. Device functions as a physical containment vessel to prevent accidental needle sticks or injury from sharp medical waste. Used by healthcare staff and patients in clinical settings. Provides secure storage for sharps until final disposal. Benefits include reduction of sharps-related injury risk and improved infection control.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable plastic container for sharps containment. Form factor designed for puncture resistance and secure closure. No electronic components, software, or active energy sources.

Indications for Use

Indicated for safe disposal of hazardous sharps in healthcare facilities. Suitable for use by healthcare professionals and general public (Over-The-Counter).

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2008

Mr. Weifeng Zhong General Manager Zhejiang Gongdong Medical Plastic Factory Beicheng Industrial Area Huangyan, Taizhou, Zhejiang CHINA 318020

Re: K082042

Trade/Device Name: Gongdong Disposable Sharps Container Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: August 29, 2008 Received: August 29, 2008

Dear Mr. Zhong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Thornwell lend m y fore//

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K082042

Device Name: Gongdong Disposable Sharps Container

Indications For Use:

The Gongdong Disposable Sharps Container is intended to be used in the healthcare facilities for the safe disposal of hazardous sharps.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ___X____ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shade H Murphy, MD

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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