← Product Code [MMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK) · K101567 # SHARPS CONTAINER (K101567) _Cixi Leinuo Plastic Co., Ltd. · MMK · Sep 2, 2010 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K101567 ## Device Facts - **Applicant:** Cixi Leinuo Plastic Co., Ltd. - **Product Code:** [MMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK.md) - **Decision Date:** Sep 2, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps. ## Device Story Sharps Container Lns-T1 is a single-use, injection-molded polypropylene container designed for safe disposal of used needles and syringes. Used in hospitals, clinics, labs, and emergency vehicles by healthcare professionals. Features include biohazard warning labels, puncture-resistant walls, and a locking lid mechanism to prevent accidental needle sticks and leakage during storage, handling, or transport. Device sits on floors or desks; provides physical containment of medical waste to reduce sharps-related injury risk. ## Clinical Evidence Bench testing only. Device performance validated against BS7230:1990, ASTM F2132:2008, and OSHA 29CFR1910 standards for mechanical and environmental safety. No clinical data provided. ## Technological Characteristics Material: Injection-molded polypropylene. Dimensions: 10.5cm x 8cm x 18cm. Volume: 1.0L. Thickness: 1.2mm (body), 1.3mm (lid). Features: Biohazard labeling, locking lid, puncture/leak-resistant design. Standards: BS7230:1990, ASTM F2132:2008, OSHA 29CFR1910. ## Regulatory 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. ## Predicate Devices - Sharps Away Disposable Containers ([K072667](/device/K072667.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K 101567 2 2010 SEP # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: June 7, 2009 1. Company and Correspondent making the submission: Name - Cixi Leinuo Plastic Co., Ltd Address - No. 56, Luoming South Road, Guanhaiwei Town, Cixi , Ningbo, Zhejiang, China,315316 Telephone - +86-574-63673001 Fax - +86-574-63671001 Contact - Mr. Leiping Wang Email – cxleinuo@163.com 2. Device : Trade/proprietary name: Sharps Container Lns-T1 Common Name : Sharps Container Classification Name : Container, Sharps Predicate Devices: | Model | Manufacturer | K Number | Submitted Device | |-----------------------------------------|-----------------|----------|------------------| | Sharps Away
Disposable
Containers | Solutions, Inc. | K072667 | Lns-T1 | 3. Classifications Names & Citations : 21CFR 884.6120, MMK, Sharps Container, Class II 15 of 58 {1}------------------------------------------------ #### 4. Description : 4.1 General The Sharps Container is a piece of equipment used in hospitals, physicians' offices, dental offices, laboratories, home health areas, patient rooms and other locations of medical waste. The sharps container is designed to safely contain used needles or syringes and prevent accidental needle sticks from used syringes or needles. ## Structure - The device is made of injected molded polypropylene material. The material . is made of molded plastic into a specific shape. The actual shape is designed to sit on the floor or a desk. - · On the outer casing of all the sharps containers is the Biohazard Warning label in Orange, noticeably displayed. - The molded plastic container is designed and manufactured such that there . will be no leakage during storage, handling or transport. for the daving thinker | Please refer to the table below for the device thickness. | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Comments of the comments of the comments of the comments of | - A L L L L L L L L L L L L L L L L B L B R L B R B R B R B R B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L | | | | | | | | | | Model Name | Size (cm) | Volume (L) | Empty
Weight
(grams) | Thickness of material | |------------|-----------|------------|----------------------------|-----------------------| | LNS-T1 | 10.5*8*18 | 1.0 | 80g | body:1.2mm lid:1.3mm | 5. Indication for use : Device Name: Lns-T1 Indications for Use: The sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps. {2}------------------------------------------------ 6. Comparison with predicate device :- Please see the next page : . . . . . . . . . . . and the same of the same of the same : : : . 1. September 2017 and the comments of the comments of the comments of {3}------------------------------------------------ | Element of comparison | Subject Device | Claimed SE Device | |---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Company | Cixi Leinuo Plastic Co., Ltd. | Solutions Inc. | | FDA510(K) Number | N/A | K072667 | | Device Name | Sharps Container | Sharps Away Disposable Container | | Intended use(s) | Leinuo sharps containers are
intended to be used for the safe
disposal of hazardous sharps. | Sharps Away Disposable Containers are
intended to be used for the safe disposal
of hazardous sharps. | | Target Population | Healthcare professional | Healthcare professional | | where used: Hospital, Physicians
Offices, Dental offices, Laboratories,
Home health, Patient room, etc. | Yes | Yes | | Material | Polypropylene | Polypropylene | | Sharps closure | Flaps are closed and locked in place
for removal | Flaps are closed and locked in place for
removal | | Impact Resistance | Yes | Yes | | Puncture Resistance | Yes | Yes | | Leak Resistance | Leak-proof on the sides and bottom | Leak-proof on the sides and bottom | | Single Use | Yes | Yes | 18 of 58 : {4}------------------------------------------------ - 7. Performance Testing : Mechanical, environmental safety and performance testing have been accomplished according to BS7230:1990, ASTM F2132:2008 and OSHA 29CFR1910. The product passed all tests. These tests demonstrate this product is substantially equivalent to the predicate device. ## 8. Conclusions: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification The Cixi Leinuo Plastic Co., Ltd. Sharps Container, Model Lns-T1 is substantially equivalent to the predicate devices as described herein. - 9. Cixi Leinuo Plastic Co., Ltd will update and include in a summary any other information deemed Yeasonably necessary by the FDA. END {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Cixi Leinuo Plastic Company, Limited C/O Mr. Charles Mack IRC 77325 Joyce Way Echo, Oregon 97826 S.. 2 2010 Re: K101567 Trade/Device Name: Sharps Container, Models Lns-T1 Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: March 25, 2010 Received: June 4, 2010 Dear Mr. Mack: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {6}------------------------------------------------ Page 2- Mr. Mack 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use Device Name: Sharps Container, Models Lns-T1 Indications For Use: The sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps. Prescription Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elizabeth T. Clavie-Will (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital Division Control, Dental Devices 510(k) Number: KI01567 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K101567](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K101567) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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