K Number

Device Name

SHARPS CONTAINER

Manufacturer

CIXI LEINUO PLASTIC CO. LTD

Date Cleared

2010-09-02

(90 days)

Product Code

MMK

Regulation Number

880.5570

Intended 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 Description

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. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K072667

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical design and safety features of a sharps container, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is a sharps container designed for the safe disposal of hazardous sharps, not for treating or diagnosing any medical condition.

Diagnostic

No
The device is a sharps container used for the safe disposal of hazardous sharps, not for diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it is made of injected molded polypropylene material and is a physical container for sharps disposal. It does not mention any software components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the safe disposal of hazardous sharps in healthcare settings. This is a physical containment and safety function, not a diagnostic test performed on biological samples in vitro (outside the body).
Device Description: The description focuses on the physical characteristics of the container (material, shape, safety features) for containing sharps. It does not describe any components or processes related to analyzing biological specimens.
Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on in vitro analysis.
Performance Studies: The performance studies mentioned are related to mechanical and environmental safety, which are relevant to the physical function of a sharps container, not the analytical performance of an IVD.

In summary, the device is a container for safely disposing of medical waste, which is a medical device but not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

MMK

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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. Healthcare professional.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072667

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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

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

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

Classifications Names & Citations :

21CFR 884.6120, MMK, Sharps Container, Class II

15 of 58

4. Description :

4.1 General

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 | 10.5818 | 1.0 | 80g | body:1.2mm lid:1.3mm |

Indication for use : Device Name:

Lns-T1

Indications for Use:

Comparison with predicate device :- Please see the next page

. . . . . .

. . . .

and the same of the same of the same

September 2017

and the comments of the comments of the comments of

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

1. 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.

1. Cixi Leinuo Plastic Co., Ltd will update and include in a summary any other information deemed Yeasonably necessary by the FDA.
  END

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.

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

Indications for Use

Device Name: Sharps Container, Models Lns-T1 Indications For Use:

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