Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong
Device Facts
| Record ID | K253773 |
|---|---|
| Device Name | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong |
| Applicant | Taizhou Huangyan Guanhong Plastic Steel Products Factory |
| Product Code | MMK · General Hospital |
| Decision Date | May 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
Indications for Use
Guanhong Sharps containers are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.
Device Story
Injection-molded polypropylene containers; single-use; non-sterile; designed for safe disposal/transport of contaminated medical sharps. Used in healthcare facilities by qualified personnel; not for patient contact. Features include puncture/leak/impact resistance; various lid configurations (hinged, rotary, sliding, counter-balanced); and mounting options (free-standing, wall brackets). Containers act as secure enclosures for sharps until final disposal. Benefits include reduced risk of sharps-related injury to healthcare staff.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Materials: Polypropylene (PP). Construction: Injection molded. Energy: None (mechanical). Connectivity: None. Sterilization: Non-sterile. Standards: ISO 23907-1:2019, 49 CFR 178.606/608, OSHA 1910.1030. Features: Puncture/leak/impact resistant, various lid types, mounting accessories.
Indications for Use
Indicated for safe disposal of hazardous sharps (hypodermic needles, syringes, lancets, blood needles) by qualified personnel in healthcare or similar facilities. Not for use in areas with 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
- Maxcon Sharps Container (K180984)
Reference Devices
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
May 22, 2026
Taizhou Huangyan Guanhong Plastic Steel Products Factory
Chenghao Lu
General Manager
Chengjiang St. Industrial Park, Huangyan District
Taizhou, Zhejiang 318020
China
Re: K253773
Trade/Device Name: Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong Sharps Container (GH-9FY); Guanhong Sharps Container (GHW-3FY); Guanhong Sharps Container (GHW-5FY); Guanhong Sharps Container (GHW-2FY2); Guanhong Sharps Container (GHW-3FY2); Guanhong Sharps Container (GH-1RA)
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: MMK
Dated: April 21, 2026
Received: April 22, 2026
Dear Chenghao Lu:
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 (the 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 available 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
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253773 - Chenghao Lu
Page 2
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
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K253773 - Chenghao Lu
Page 3
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
**STEPHEN A. ANISKO -S**
Digitally signed by
**STEPHEN A. ANISKO -S**
Date: 2026.05.22
16:08:57 -04'00'
Stephen Anisko
Acting Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253773 | |
| Device Name | |
| Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong Sharps Container (GH-9FY); Guanhong Sharps Container (GHW-3FY); Guanhong Sharps Container (GHW-5FY); Guanhong Sharps Container (GHW-2FY2); Guanhong Sharps Container (GHW-3FY2); Guanhong Sharps Container (GHW-5FY2); Guanhong Sharps Container (GH-1RA) | |
| Indications for Use (Describe) Guanhong Sharps containers are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access. | |
| Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ 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." | |
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K253773
510(k) Summary
K253773
The assigned 510(k) number is: K253773
1. Submitted By:
Taizhou Huangyan Guanhong Plastic Steel Products Factory
Chengjiang Street Industrial Park, Huangyan District, Taizhou Zhejiang, CN 318020 Establishment
Registration Number: 3030519472
2. Primary Contact:
Chenghao Lu
General Manager
Taizhou Huangyan Guanhong Plastic Steel Products
Factory Phone: 86-576-8462538
Email: quality@superg-med.com
3. Name of the Device:
Device Name: Guanhong Sharps Container
Trade Name: Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4);
Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS);
Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong Sharps Container (GH-9FY); Guanhong Sharps Container (GHW-3FY); Guanhong Sharps Container (GHW-5FY); Guanhong Sharps Container (GHW-2FY2); Guanhong Sharps Container (GHW-3FY2); Guanhong Sharps Container (GHW-5FY2);
Guanhong Sharps Container (GH-1RA)
4. Classification Information:
Product Code: MMK
Device Class: Class II
CFR Reference: 21 CFR 880.5570
Classification: Hypodermic single lumen needle
Classification Panel: General Hospital
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Page 2 of 9
K253773
# 5. Predicate Device:
Trade name: Maxcon Sharps Container
Regulation Description: Hypodermic single lumen needle.
Product Code: MMK
Regulation Number: CFR880.5570
Device Class: II
The device 510k number is K180984, manufactured by Ningbo Maxcon Medical Technology Co., Ltd, located in No.228,Dongxin Road, Dongqiao Town, Ningbo, Zhejiang Province, China.
# Reference Device 1:
Trade name: Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) Regulation Description: Hypodermic single lumen needle.
Product Code: MMK
Regulation Number: CFR880.5570
Device Class: II
The device 510k number is K222905, manufactured by Ningbo Maxcon Medical Technology Co., Ltd, located in No.228,Dongxin Road, Dongqiao Town, Ningbo, Zhejiang province, China.
# Reference Device 2:
Trade name: Sharps Container
Regulation Description: Hypodermic
single lumen needle. Product Code: MMK
Regulation Number: CFR880.5570
Device Class: II
The device 510k number is K201523, manufactured by Zhejiang Gongdong Medical Technology Co., Ltd, located in No.10, Beiyuan Avenue, Huangyan, Taizhou City, Zhejiang Province, China
{6}
6. Indications for Use:
Guanhong Sharps containers are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.
7. Device Description:
Guanhong Sharps Containers are of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other facilities in which medical sharps may be used. 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.
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.
Page 3 of 9
K253773
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Table 1: Description of Devices
| # | Model# | Product dimensions after assembled (LxWxH)mm | Description and dimensions of the sharps disposal aperture | Locking mechanism | with needle unwinders? | with handle? | Requirements for mounting | Weight (empty) gram | Capacity (total) | Capacity (full line) | Barrel material | Barrel dimensions (mm) | Min. Barrel thickness (mm) | Barrie color | Lid configuration | Lid material | Lid dimensions (mm) | Min. Lid thickness (mm) | Lid Color | Acceptable sites of use (patientaccess) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | GHW-1F1 | 108.1x99.9x157.5 | opening: 1: 43x30mm (LxW); opening: 2: OD 20mm; | Hinged closure | yes | no | Free standing or holder with double face adhesive tape | 85 | 0.9L | 0.72L | PP | 92.7x92.7x152 | 1.4 | Red or Yellow | Single hinged opening | PP | 108.1x99.9x16.8 | 1.5 | Clear or White | The targetpopulation s/hr qualifiedpersonnel inhealth carefacilities andOther facilitiesin whichmedicalsharps may beused. |
| 002 | GHW-1F4 | 127.2x113.8x136.1 | opening: 65*65mm (LxW) | Hinged closure | yes | no | Free standing or holder with double face adhesive tape | 85 | 1L | 0.8L | PP | 110.7x110.7x130.1 | 1.2 | Red or Yellow | Single hinged opening | PP | 127.2x113.8x12.5 | 1.08 | Clear or White | All thecontainers areintended to beused in areaswhere there areunsupervisedpatient access. |
| 003 | GH-6FA | 235.9x205.2x294.3 | Elliptical opening: | Rotary door | yes | yes | Free standing or holder with double face adhesive tape | 463 | 6.5L | 5.2L | PP | 235.9x205.2x241.7 | 1.8 | Red or Yellow | Single rotating opening | PP | 197.4x197.4x58.5 | 1.4 | Red & Yellow | |
| 004 | GHW-2FR | 160.3x116.3x179.1 | Fan shaped opening: R45mm × 160" | Rotary door | yes | no | Free standing or holder with double face adhesive tape | 179 | 2L | 1.6L | PP | 156.8x113.3x161.6 | 1.5 | Red or Yellow | Single rotating opening | PP | 160.3x116.3x20 | 1.7 | Clear & Red | |
| 005 | GHW-8FR | 396.9x276.7x440 | Fan shaped opening: R45mm × 160" Large rectangle opening: 228*12 1mm | Semi-circular opening: Rotary door Large rectangle opening: Hinged closure | yes | yes | Free standing or holder with double face adhesive tape | 1095 | 8 Gallon | 6.4 Gallon | PP | 411.4x267.2x430 | 1.8 | Red or Yellow | Rotating opening & hinged opening | PP | 396.9x276.7x21.85 | 1.8 | Clear & Red | |
| 006 | GH-3FS | 201.6*158.4*130.8 | Irregular Opening | Sliding door | yes | no | Free standing or holder with double face adhesive tape | 125 | 2.5L | 2L | PP | 196.9x156.7x120 | 1 | Red or Yellow | Single sliding opening | PP | 201.6*158.4*16.3 | 1 | White & Red | |
| 007 | GHW-15FS | 380.5x237.1x263 | Irregular Opening | Sliding door | yes | yes | Free standing or holder with double face adhesive tape | 587 | 15L | 12L | PP | 380.5x237.1x253 | 1.4 | Red or Yellow | Single sliding opening | PP | 362.7x226.9x23 | 2 | Clear & Red | |
| 008 | GHW-27FS | 382.7x276.9x386.8 | Rectangle opening: 238x91 mm | Sliding door | yes | no | Free standing or holder with double face | 939 | 27L | 21.6L | PP | 377.8x272x385.4 | 1.5 | Red or Yellow | Single sliding opening | PP | 382.7x276.9x76.23 | 1.7 | White & Red | |
| 009 | GH-SFSW | 258.7x175.1x151.9 | Irregular opening: 176*70 mm | Sliding door | yes | no | Free standing or holder with double face adhesive tape | 205 | 5L | 3.5L | PP | 256x173.2x138.6 | 1.8 | Red or Yellow | Single sliding opening | PP | 258.7x175.1x20.8 | 1.5 | White & Red | |
| 010 | GHW-3FT | 246.6x201.1x135.1 | Fan shaped opening: R45*120" | Rotary door | yes | yes | Free standing or holder with double face | 176 | 2.5 Quart | 2 Quart | PP | 241.8x199.6x120.3 | 1.2 | Red or Yellow | Single rotating opening | PP | 246.6*201.1*30.6 | 1.6 | Clear & Red | |
| 011 | GHW-4FT | 197.8x131.9x211.7 | Irregular opening: 170*45.3mm | Hinged closure | yes | yes | Free standing or holder with double face adhesive tape | 229 | 4L | 3.2L | PP | 197.8x131.9x201.8 | 1.3 | Red or Yellow | Single hinged opening | PP | 196.7x127.8x18.9 | 0.85 | Clear & Red | |
K253773
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| 012 | GHW-5FT | 246.6x201.1x168 | Fan shaped opening: R44*120° | Rotary door | yes | yes | Free standing or holder with double face adhesive tape | 251 | SL | 3.5L | PP | 241.8x199.6x144.5 | 1 | Red or Yellow | Single rotating opening | PP | 246.6*201.1*3 0.6 | 1.6 | Clear & Red |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 013 | GHW-8FT | 246.6x201.1x271.6 | Fan shaped opening: R44*120° | Rotary door | yes | yes | Free standing or holder with double face adhesive tape | 356 | BL | 6.4L | PP | 241.8x199.6x248 | 1 | Red or Yellow | Single rotating opening | PP | 246.6*201.1*3 0.6 | 1.6 | Clear & Red |
| 014 | GH-9FY | 326.4x202.1x282.6 | Rectangle opening: 235*48 mm | Counter balanc | Yes | yes | Locking wall bracket | 472 | 9L | 7.2L | PP | 326.4x191.9x236 | 1.6 | Red or Yellow | Counter Bal | PP | 303.8x202.1x5 4.5 | 1.4 | Clear or White |
| 015 | GHW-3FY | 347.05x149.26x417.93 | Rectangle opening: 220*64 mm | Counter balanc | No | yes | Locking wall bracket | 578 | 3 Gallon | 2.4 Gallon | PP | 347.05x14 3.87x339 | 1.4 | Red or Yellow | Counter Bal | PP | 315.5x151.3x6 0.8 | 1.7 | Clear or White |
| 016 | GHW-5FY | 272x117x301.6 | Rectangle opening: 217*47 mm | Counter balanc | No | no | Locking wall bracket | 387 | 5 Quart | 4 Quart | PP | 261.8x115x 229.5 | 1.35 | Red or Yellow | Counter Bal | PP | 272x117x52.7 | 1.2 | Clear or White |
| 017 | GHW-2FY2 | 275.2x175x291.3 | Rectangle opening: 194*47 mm | Counter balanc | Yes | yes | Locking wall bracket | 359 | 2 Gallon | 1.6 Gallon | PP | 275.2x171x 244 | 1.3 | Red or Yellow | Counter Bal | PP | 260x175x56 | 1.3 | Clear or White |
| 018 | GHW-3FY2 | 378.2x182.4x338.2 | Rectangle opening: 240*75.5mm | Counter balanc | Yes | yes | Locking wall bracket | 622 | 3 Gallon | 2.4 Gallon | PP | 378.2x178.74x279.39 | 1.5 | Red or Yellow | Counter Bal | PP | 364.6x182.4x7 6.26 | 1.3 | Clear or White |
| 019 | GHW-5FY2 | 309.6x115x290.6 | Rectangle opening: 194*33.8mm | Counter balanc | Yes | yes | Locking wall bracket | 368 | 5.4 Quart | 4.32 Quart | PP | 309.6x115x 248.7 | 1.6 | Red or Yellow | Counter Bal | PP | 266x114.7x49.4 | 1.4 | Clear or White |
| 020 | GH-TRA | Dia124.2 x H109.2 | Fan shaped opening: R44.2mm × 120° | Rotary door | yes | no | Free standing or holder with double face adhesive tape | 63 | 0.6L | 0.48L | PP | Dia122 x H88.73 | 0.9 | Red or Yellow | Single rotate | PP | Dia124.2 x H27.5 | 1 | Red & Yellow |
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K253773
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# 8. Comparing to Predicate Device:
Table 2: Comparison of Technological Characteristics
| Characteristic | Submitted Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | Comparison |
| --- | --- | --- | --- | --- | --- |
| 510(k) | K253773 | K180984 | K222905 | K201523 | N/A |
| Device Name | Guanhong Sharps Container | Maxcon Sharps Container | Maxcon Sharps container | Sharps container | N/A |
| Product code | MMK | MMK | MMK | MMK | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | II | II | Same |
| Indications for Use | Guanhong Sharps containers are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access. | Maxcon Sharps containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. 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. | Maxcon Sharps containers are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access. | 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. | Same |
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K253773
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K253773
| Size | GHW-1F1, 0.9L ; GHW-1F4, 1 L ; GH-6FA, 6.5L ; GHW-2FR, 2L ; GHW-8FR, 8 Gallon ; GH-3FS, 2.5L; GHW-15FS, 15L; GHW-27FS, 27L; GH-5FSW, 5L; GHW-3FT, 2.5Quart; GHW-4FT, 4L; GHW-5FT, 5L; GHW-8FT, 8L; GH-9FY, 9L; GHW-3FY, 3Gallon; GHW-5FY, 5Quart; GHW-2FY2, 2Gallon; GHW-3FY2, 3Gallon; GHW-5FY2, 5.4 Quart; GH-1RA, 0.6L | MA1122, 2.2 QT ; MA1352, 8G | MA1112, 1 QT; MA1212, 5.4 QT; MA1213, 5.4 QT | GDC-03-X, 2.972L ; GDC-05-X, 5.234L; GDC-07-X, 6.875L; SC02Q, 1.063L; SC06G, 21,024L. | Different |
| --- | --- | --- | --- | --- | --- |
| Dimensions (mm) (L x W x H) | Various See device description | MA1122, 160x120x181mm; MA1352, 390x276x435mm | MA1112, 101.82x108.31x154mm; MA1212, 311.13x113.85x291.06mm; MA1213, 310x116.2x315.31mm | GDC-03-X, 183.4*153.3*189.3mm; GDC-05-X, 221.0*195.9*217.5mm; GDC-07-X, 240.6*218.8*230.0mm; SC02Q, 108.6*88.3*222.8mm; SC06G, 377.0*235.9*415.2mm. | Different |
| Single or re-usable use | Single use/disposable | Single use/disposable | Single use/disposable | Single use/disposable | Same |
| Weight range | 63 to 1095g | 175 to 1220g | 90.6 to 422g | 77.85 to 801.56g | Different |
| No. of Pieces | 2 to 4 | 2 | 2 to 4 | 2 to 4 | Same |
| Sterile or not | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Material | Poly-propylene (P.P) | Poly-propylene (P.P) | Poly-propylene (P.P) | Polypropylene (PP), Copolymerization polypropylene | Same |
| Body Color | Red/yellow base | Red base, | Red base, | Red/yellow base, | Same |
{11}
| | Translucent/Red/White/Yellow lid | Translucent/red lid | Translucent/white lid | Translucent/red/white lid | |
| --- | --- | --- | --- | --- | --- |
| Clarity | Opaque/translucent | Opaque/translucent | Opaque/translucent | Opaque/translucent | Same |
| Performance testing (puncture, impact, drop, stability, integrity) | Pass | Pass | Pass | Pass | Same |
| Standards | ISO 23907-1:2019 | ISO 23907-1:2019 | ISO 23907-1:2019 | ASTM F2132-01 (Reapproved 008e1) ISO23907 | Same |
| Lid Configuration | Hinged, closure, rotary door, sliding door, counter balanced door | Rotary door | Hinged closure, counter balanced door | Revolving cap, Slid cap | Same |
| Accessories | Free standing or holder with double face adhesive, locking wall bracket | Free standing or double face adhesive tape | Holder with double face adhesive tape, locking wall bracket | Free standing | Same |
## Summary of technological characteristics
1) The same indication for use;
2) The same product structure, disposable and non-sterile sharps containers;
3) The same method of manufacture: injection molded of polypropylene;
4) The same lid configuration;
5) complied with same performance testing standard.
Although the subject device and predicate device are different on size, dimensions, weight range, the differences in technological characteristics do not impair the subject devices from their intended functions of disposal and storage of sharp waste
K253773
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K253773
# 9. Summary of Non-Clinical Tests :
Table 3: Non-Clinical Performance Testing
| NO. | Test Name | Test Standards | Test Results |
| --- | --- | --- | --- |
| 1 | Container Stability | ISO23907-1:2019 | Passed |
| 2 | Strength of Handles | ISO23907-1:2019 | Passed |
| 3 | Resistance to penetration | ISO23907-1:2019 | Passed |
| 4 | Resistance to damage and leakage after dropping | ISO23907-1:2019 | Passed |
| 5 | Resistance to damage and leakage after toppling | ISO23907-1:2019 | Passed |
| 6 | Stacking Test | 49CFR 178.606 | Passed |
| 7 | Vibration Test | 49CFR 178.608 | Passed |
| 8 | Leak proof on the sides and bottom | OSHA Regulations (Standards - 29 CFR) Bloodborne Pathogens. 1910.1030, (d)(2)(viii)(C) | Passed |
| 9 | Sharps access and closure for repeated openings and closings | Enterprise standards - Product Technical Requirements (Sharps container) GH-SG-002-1 | Passed |
| 10 | Usable capacity test | Enterprise standards - Product Technical Requirements (Sharps container) GH-SG-002-1 | Passed |
# 10. Discussion of Clinical Tests Performed:
There was no clinical testing required to support the medical device.
# 11. Conclusions:
The conclusions drawn from the nonclinical tests demonstrate that the Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong Sharps Container (GH-9FY); Guanhong Sharps Container (GHW-3FY); Guanhong Sharps Container (GHW-5FY); Guanhong Sharps Container (GHW-2FY2); Guanhong Sharps Container (GHW-3FY2); Guanhong Sharps Container (GHW-5FY2); Guanhong Sharps Container (GH-1RA) subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K180984.
