Who is the manufacturer of Sharps container?

Zhejiang Gongdong Medical Technology Co., Ltd. filed the 510(k) submission for Sharps container (K201523).

What is the FDA product code for Sharps container?

MMK. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Sharps container?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Sharps container?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sharps container

Q: What are the predicate devices for Sharps container?

Tiger Sharps container (K190240).

K201523 · Zhejiang Gongdong Medical Technology Co., Ltd. · MMK · Nov 12, 2020 · General Hospital

Device Facts

Record ID	K201523
Device Name	Sharps container
Applicant	Zhejiang Gongdong Medical Technology Co., Ltd.
Product Code	MMK · General Hospital
Decision Date	Nov 12, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5570
Device Class	Class 2

Intended Use

Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.

Device Story

Sharps containers serve as puncture-resistant, leak-resistant, and impact-resistant receptacles for used medical sharps; intended for safe disposal and transport. Operated by qualified personnel in healthcare facilities; used in areas without unsupervised patient access. Devices are single-use, disposable, and non-sterile. Features include various lid configurations (folding, revolving, sliding) and locking mechanisms to secure contents. Some models include needle unwinding features. Containers are free-standing or wall-mounted. By safely enclosing hazardous sharps, the device prevents accidental injury to healthcare workers and others during handling and disposal.

Clinical Evidence

No clinical data. Bench testing only. Performance validated against ASTM F2132-01 (anti-penetrability), ISO 23907 (drop, stability, handle strength), and 49 CFR 178.606/178.608 (stack and vibration tests). All tests passed.

Technological Characteristics

Materials: Polypropylene (PP) and Copolymerization PP; ABS for bottom/keys in specific models. Construction: Injection molded. Features: Puncture/leak/impact-resistant, closable, stable. Mounting: Free-standing or locking wall bracket. Non-sterile. No patient contact.

Indications for Use

Indicated for safe disposal of hazardous sharps (needles, syringes, lancets) in healthcare and other facilities by qualified personnel. Intended for use in areas without unsupervised patient access.

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.

Predicate Devices

Tiger Sharps container (K190240)

Related Devices

K973911 — 2 GALLON ALTERNATE CARE SHARPS CONTAINER · Sage Products, Inc. · Oct 29, 1997
K980490 — SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS · Sage Products, Inc. · Feb 24, 1998
K190240 — Tiger Sharps Containers · International Marketing Specialists, Inc. · May 31, 2019
K211464 — Nitta M&T Safety Box · Nitta M&T (Thailand) Co., Ltd. · Sep 14, 2021
K211890 — Promisemed Sharps container · Promisemed Hangzhou Meditech Co., Ltd. · Nov 17, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 12, 2020 Zhejiang Gongdong Medical Technology Co., Ltd % Ivy Wang Techinical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai, Shanghai 200122 China Re: K201523 Trade/Device Name: Sharps container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: October 16, 2020 Received: October 16, 2020 Dear Ivy Wang: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K201523 Device Name Sharps Container Indications for Use (Describe) Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ | Model No. | Capacity (full line) | capacity (total) | Weight | Dimension (mm) | Thickness (mm) | Requirements for mounting | Acceptable sites of use | Description and Dimension of disposal aperture(cm) | |-----------|-------------------------|---------------------|---------|-------------------|-------------------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | GDC-03-F | 2143ml | 2972ml | 224.80g | 188.4*158.1*193.2 | 1.4 | Free standing | | 8.2*5.2 | | GDC-03-X | 2143ml | 2972ml | 234.15g | 183.4*153.3*189.3 | 1.4 | Free standing | The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All the containers are intended to be used in areas where there is no unsupervised patient access. | 16 sq. | | GDC-05-F | 4049ml | | 320.50g | 226.3*199.0*218.5 | 1.5 | Free standing | | 9.5*5.5 | | GDC-05-X | 4049ml | 5234ml | 322.76g | 221.0*195.9*217.5 | 1.5 | Free standing | | 21sq. | | GDC-07-F | 5288ml | 6875ml | 435.28g | 241.4*220.9*231.7 | 1.7 | Free standing | | 9.5*5.5 | | GDC-07-X | 5288ml | 6875ml | 425.32g | 240.6*218.8*230.0 | 1.7 | Free standing | | 21sq. | | GDC-013-X | 10038ml | 13253ml | 628.54g | 281.8*252.5*307.8 | 1.8 | Free standing | | 32sq. | | SC-01Q | 670ml | 763ml | 77.53g | 108.2*88.4*173.7 | 1.05 | Free standing | | 5*3.7 | | SC-02Q | 910ml | 1063ml | 77.85g | 108.6*88.3*222.8 | 1.2 | Free standing | 5*3.7 | | | SC-05Q | 4367ml | 5111ml | 513.61g | 270.3*116.1*289.5 | 1.3 | Free standing Locking wall bracket | 22*4.5 | | | SC-01G | 2623ml | 3863 | 220.72g | 257.3*174.5*155.2 | 1.15 | Free standing | 14*5.5 | | | SC-02G | 6066ml | 7424ml | 489.21g | 257.3*175.0*259.5 | 1.15 | Free standing Locking wall bracket | 14*6 | | | SC-06G | 14013ml | 21024ml | 801.56g | 377.0*235.9*415.2 | 1.5 | Free standing | 21*4.5 | | {4}------------------------------------------------ | Model No. | Material description | Color | lid configurations | Lock Method | Unwinding feature | |---------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | GDC-03-F | Cap: PP; Body: Copolymerization PP | Cap: Semitransparent; Body: Yellow | Folding cap | Buckle on fold over cover and fasten cover | Located in the lid and above the containment area. The unwinder has a round entry port for the needle to pass through, allowing it to be fully enclosed within the container. | | GDC-03-X | Cap, small cover, handle: PP; Body: Copolymerization PP | Cap: Semitransparent; Small cover and handle: Red; Body: Yellow | Revolving cap | There is a protruding small cylinder on the reverse side of the small red cover that can rotate, and there is a small round hole on the cover. When the small cylinder rotates to the position of the small round hole, the two kinds of small cylinders cooperate and buckle each other. | The models GDC-03-F, GDC-03-X, DC-05-F, GDC-05-X, GDC-07-F, GDC-07-X, GDC-13--X SC-01Q, SC-06G, SC-02Q have the needle unwinding | | GDC-05-F | Cap: PP; Body: Copolymerization PP | Cap: Semitransparent; Body: Yellow | Folding cap | Buckle on fold over cover and fasten cover | features | | GDC-05-X | Cap, K7:K9small cover, handle: PP; Body: Copolymerization PP | Cap: Semitransparent; Small cover and handle: Red; Body: Yellow | Revolving cap | There is a protruding small cylinder on the reverse side of the small red cover that can rotate, and there is a small round hole on the cover. When the small cylinder rotates to the position of the small round hole, the two kinds of small cylinders cooperate and buckle each other. | | | GDC-07-F | Cap: PP; Body: Copolymerization PP | Cap: Semitransparent; Body: Yellow | Folding cap | Buckle on fold over cover and fasten cover | | | GDC-07-X | Cap, small cover, handle: PP; Body: Copolymerization PP | Cap: Semitransparent; Small cover and handle: Red; Body: Yellow | Revolving cap | There is a protruding small cylinder on the reverse side of the small red cover that can rotate, and there is a small round hole on the cover. When the small cylinder rotates to the position of the small round hole, the two kinds of small cylinders cooperate and buckle each other. | | | GDC-013- X | Cap, small cover: PP; Body: Copolymerization PP | Cap: Semitransparent; Small cover and handle: Red; Body: Yellow | Revolving cap | There is a protruding small cylinder on the reverse side of the small red cover that can rotate, and there is a small round hole on the cover. When the small cylinder rotates to the position of the small round hole, the two kinds of small cylinders cooperate and buckle each other. | | | SC-01Q | Cap, small cover: PP; Body: Copolymerization PP | Cap: White; Small cover and handle: | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | | SC-02Q | Cap, small cover: PP; Body: Copolymerization PP | Cap: Semitransparent; Body: Red | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | | SC-05Q | Cap and small cover: PP; Body: Copolymerization PP; Bottom and keys: ABS | Cap: White; Small cover: Red, Body Red; Bottom and key: Grey | Revolving cap | Small cap could revolving inside and fasten tight with the buckle in the cap | | | SC-01G | Cap, small cover: PP; Body: Copolymerization PP | Cap: White; Small cover and handle: Semitransparent; Body: Red | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | | SC-02G | Cap and small cover: PP; Body: Copolymerization PP; Bottom and keys: ABS | Cap: White; Small cover and handle: Semitransparent; Body: Red | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | | SC-06G | Cap, small cover: PP; Body: Copolymerization PP | Cap: White; Small cover and handle: Semitransparent; Body: Red | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | {5}------------------------------------------------ {6}------------------------------------------------ - {7}------------------------------------------------ ### 510(K) Summary Date of Summary prepared: 2020-11-11 ### A. Applicant: Zhejiang Gongdong Medical Techonology Co., Ltd Address: No.10, Beiyuan Avenue, Huangyan, Taizhou City, Zhejiang Province, China Contact Person: WEIFENG ZHONG Tel: 86 - 576 - 84081133 Email: fda.sungo@gmail.com Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com ### B. Device: Trade Name: Sharps Container Common Name: container, sharps Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: MMK Review Panel: General Hospital ### C. Predicate device: | Manufacturer | Predicate Device | 510(k) Number | Submitted Device | |---------------------------------------------|------------------------|---------------|----------------------------| | International Marketing Specialists Inc. | Tiger Sharps container | K190240 | Tiger Sharps Containers | ### D. Indications for Use: {8}------------------------------------------------ Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The Containers are single-use, disposable, non-sterile containers intended to be used for health- - care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. The following Sharps Container models and accessories are described in this submission: | Model No. | Capacity (full line) | capacity (total) | Weight | Dimension (mm) | Thickness (mm) | Requirements for mounting | Acceptable sites of use | Description and Dimension of disposal aperture(cm) | |-----------|-------------------------|---------------------|---------|-------------------|-------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | GDC-03-F | 2143ml | 2972ml | 224.80g | 188.4*158.1*193.2 | 1.4 | Free standing | The target population is for qualified personnel in health care facilities and other facilities in | 8.2*5.2 | | GDC-03-X | 2143ml | 2972ml | 234.15g | 183.4*153.3*189.3 | 1.4 | Free standing | health care facilities and other facilities in | 16 sq. | | GDC-05-F | 4049ml | | 320.50g | 226.3*199.0*218.5 | 1.5 | Free standing | which medical sharps may be used. All the containers are | 9.5*5.5 | | GDC-05-X | 4049ml | 5234ml | 322.76g | 221.0*195.9*217.5 | 1.5 | Free standing | be used. All the containers are intended to be used in areas | 21sq. | | GDC-07-F | 5288ml | 6875ml | 435.28g | 241.4*220.9*231.7 | 1.7 | Free standing | where there is no unsupervised | 9.5*5.5 | | GDC-07-X | 5288ml | 6875ml | 425.32g | 240.6*218.8*230.0 | 1.7 | Free standing | patient access. | 21sq. | | GDC-013-X | 10038ml | 13253ml | 628.54g | 281.8*252.5*307.8 | 1.8 | Free standing | | 32sq. | | SC-01Q | 670ml | 763ml | 77.53g | 108.2*88.4*173.7 | 1.05 | Free standing | | 5*3.7 | | SC-02Q | 910ml | 1063ml | 77.85g | 108.6*88.3*222.8 | 1.2 | Free standing | | 5*3.7 | | SC-05Q | 4367ml | 5111ml | 513.61g | 270.3*116.1*289.5 | 1.3 | Free standing Locking wall bracket | | 22*4.5 | | SC-01G | 2623ml | 3863 | 220.72g | 257.3*174.5*155.2 | 1.15 | Free standing | | 14*5.5 | | SC-02G | 6066ml | 7424ml | 489.21g | 257.3*175.0*259.5 | 1.15 | Free standing Locking wall bracket | | 14*6 | | SC-06G | 14013ml | 21024ml | 801.56g | 377.0*235.9*415.2 | 1.5 | Free standing | | 21*4.5 | Table1: specification of the sharps container {9}------------------------------------------------ {10}------------------------------------------------ | Model No. | Material description | Color | lid configurations | Lock Method | Unwinding feature | |---------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | GDC-03- F | Cap : PP ; Body : Copolymerization PP | Cap : Semitransparent ; Body : Yellow | Folding cap | Buckle on fold over cover and fasten cover | | | GDC-03- X | Cap, small cover, handle : PP ; Body : Copolymerization PP | Cap : Semitransparent ; Small cover and handle: Red; Body : Yellow | Revolving cap | There is a protruding small cylinder on the reverse side of the small red cover that can rotate, and there is a small round hole on the cover. When the small cylinder rotates to the position of the small round hole, the two kinds of small cylinders cooperate and buckle each other. | Located in the lid and above the containment area. The unwinder has a round entry port for the needle to pass through, allowing it to be fully enclosed within the container. The models GDC-03-F, GDC-03-X, DC-05-F, GDC-05-X, GDC-07-F, GDC-07- X, GDC-13-X, SC-01Q, SC-06G, SC-02Q have the needle unwinding features. | | GDC-05- F | Cap : PP ; Body : Copolymerization PP | Cap : Semitransparent ; Body : Yellow | Folding cap | Buckle on fold over cover and fasten cover | | | GDC-05- X | Cap, K7:K9small cover, handle:PP; Body: Copolymerization PP | Cap : Semitransparent ; Small cover and handle: Red; Body : Yellow | Revolving cap | There is a protruding small cylinder on the reverse side of the small red cover that can rotate, and there is a small round hole on the cover. When the small cylinder rotates to the position of the small round hole, the two kinds of small cylinders cooperate and buckle each other. | | | GDC-07- F | Cap : PP ; Body : Copolymerization PP | Cap : Semitransparent ; Body: Yellow | Folding cap | Buckle on fold over cover and fasten cover | | | GDC-07- X | Cap, small cover, handle : PP ; Body : Copolymerization PP | Cap : Semitransparent ; Small cover and handle: Red; Body : Yellow | Revolving cap | There is a protruding small cylinder on the reverse side of the small red cover that can rotate, and there is a small round hole on the cover. When the small cylinder rotates to the position of the small round hole, the two kinds of small cylinders cooperate and buckle each other. | | | GDC-013- X | Cap, small cover : PP ; Body : Copolymerization PP | Cap : Semitransparent ; Small cover and handle: Red; Body : Yellow | Revolving cap | There is a protruding small cylinder on the reverse side of the small red cover that can rotate, and there is a small round hole on the cover. When the small cylinder rotates to the position of the small round hole, the two kinds of small cylinders cooperate and buckle each other. | | | SC-01Q | Cap, small cover : PP ; Body : Copolymerization PP | Cap : White ; Small cover and handle: Semitransparent; | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | | SC-02Q | Cap, small cover: PP ; Body : Copolymerization PP | Cap : White ; Small cover and handle: Semitransparent; Body : Red | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | | SC-05Q | Cap and small cover : PP ; Body : Copolymerization PP ; Bottom and keys : ABS | Cap: White; Small cover: Red, Body Red; Bottom and key: Grey | Revolving cap | Small cap could revolving inside and fasten tight with the buckle in the cap | | | SC-01G | Cap, small cover : PP ; Body : Copolymerization PP | Cap : White ; Small cover and handle: Semitransparent; Body : Red | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | | SC-02G | Cap and small cover : PP ; Body : Copolymerization PP ; Bottom and keys : ABS | Cap : White ; Small cover and handle: Semitransparent; Body : Red | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | | SC-06G | Cap, small cover : PP ; Body : Copolymerization PP | Cap : White ; Small cover and handle: Semitransparent; Body : Red | Slid cap | Slid the buckle on the small cap, fasten tight with cap | | {11}------------------------------------------------ ### E. Device Description: Sharps container are used to collect hazardous sharps such as needles, syringes, lancets and etc. The containers are single-use, disposable, non-sterile containers. {12}------------------------------------------------ The Sharps Container constructed of polypropylene plastic. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable, and stable. ### F. Technological Characteristics | Element of Comparison | Subject Device | Predicate Device | Result | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Manufacture | Zhejiang Gongdong Medical Techonology Co., Ltd | International Marketing Specialists Inc. | | | FDA510(K) Number | / | K190240 | -- | | Device Name | Sharps Containers | Tiger Sharps Containers | Similar | | Intended Use | Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. | Tiger Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. | Same | | Product code | MMK | MMK | Same | | Regulation Number | 21CFR880.5570 | 21CFR880.5570 | Same | | Class | II | II | Same | | Capacities | 2972ml,2972ml,5234ml,6875ml,6875ml, 13253ml,763ml,1063ml,5111ml,3863,74 24ml,21024ml | 1 Quart / 5 Quart / 2 Gallon / 2 Gallon B / 15 Liter 3 Gallon/ 8 Gallon | Analysis | | Prescribed | OTC | OTC | Same | | Weight Range (grams) | 77.53-801.56g | 109 - 1172 | Analysis | | No. of Piece | 2-3 | 2-3 | Similar | | Material | Polypropylene, Copolymerization polypropylene | Polypropylene | Similar | | Non-sterile | Yes | Yes | Same | Table 2: comparison of the proposed and Predicate device {13}------------------------------------------------ | Method of Manufacture | Injection Molded | Injection Molded | Same | |-------------------------------------------------------------------------------------|------------------|------------------|------| | Performance testing (puncture, impact, drop, stability, integrity etc.) | Pass | Pass | Same | | Disposable or Reusable? | Disposable | Disposable | Same | ### Difference analysis: The design and manufacture process of the Sharps Containers is similar to the predicate chosen. There are minor differences between the devices including Size, Capacities, Weight Range. ## G. Non-Clinical Performance Testing: Performance testing was performed to validate and verify that the Sharps Container met all the requirements of related international standards and product specifications. Results of these tests demonstrate the device meets the acceptance criteria of these standards. | NO. | Test | Test method | Purpose | Acceptance Criteria | Results | |-----|----------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | 1 | Anti-penetrability | ASTM F2132- 01(Reapproved 2008e1) | Prevent the sharps in the container from penetrating the side and bottom of the container and hurting the user. | The puncture resistance of each section of the container greater than 15 N and the puncture resistance performance should met. | Pass | | 2 | Resistance to damage and leakage after dropping | ISO 23907 | Prevent the container from breaking when falling from a height, and the sharps leak from the container. | Containers remained upside down for 60 minutes while being observed for leakage. No leakage observed and there is also no liquid leakage | Pass | | 3 | Stack Test | 49 CFR 178.606 | The container will not be damaged during storage and shipping while stacking. | The minimum height of the stack, including the test sample, is 3 meters. Upon completion of the stack test, containers observed for deformation. The containers should not be deteriorated. | Pass | ### Table 3: Non-Clinical Performance Testing {14}------------------------------------------------ | 4 | Vibration Test | 49 CFR 178.608 | Packaging cartons and products will not be damaged due to product transportation vibration | The containers should not be deteriorated. | Pass | |---|---------------------|-------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------| | 5 | Stability | ISO 23907 | Prevent the product from dumping during use. | The container should not slide or topple. | Pass | | 6 | Strength of handles | ISO 23907 | Prevent the handle from breaking or separating during use | The containers remained intact and handles should not rupture, tear, crack, or separate from the container. | Pass | Clinical Testing: Not Applicable. ## H. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K190240).