Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)

K253222 · Zhejiang Gongdong Medical Technology Co., Ltd. · MMK · Dec 22, 2025 · General Hospital

Device Facts

• Record ID: K253222
• Device Name: Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
• Applicant: Zhejiang Gongdong Medical Technology Co., Ltd.
• Product Code: MMK · General Hospital
• Decision Date: Dec 22, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

Gongdong sharps Containers (SCR-01Q, SCR-01G, SCR-03G) 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. 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

Gongdong Sharps Containers (SCR-01Q, SCR-01G, SCR-03G) serve as single-use, disposable, non-sterile receptacles for contaminated medical sharps. Constructed from polypropylene, the containers are puncture-resistant, leak-resistant, and impact-resistant. They feature specific apertures for sharps disposal, with models SCR-01G and SCR-03G utilizing a folding door and SCR-01Q utilizing a hinged closure. The SCR-01Q includes a holder with adhesive tape for mounting; SCR-01G and SCR-03G use locking wall brackets. Operated by qualified personnel in healthcare facilities, the device provides a secure enclosure for sharps during transport to disposal. The design ensures containment of hazardous waste, preventing accidental injury to staff and patients. No patient contact occurs during normal use.

Clinical Evidence

No clinical data. Bench testing only. Performance validated against ISO 23907-1:2019 (stability, handle strength, penetration resistance, drop/topple integrity), 49 CFR 178.606/178.608 (stacking/vibration), and OSHA 1910.1030 (leak-proof integrity). All tests passed.

Technological Characteristics

Materials: Polypropylene (P.P). Manufacturing: Injection molded. Form factor: 1 Quart, 1 Gallon, 3 Gallon containers. Mounting: Adhesive tape or locking wall brackets. Standards: ISO 23907-1:2019, 49 CFR 178.606, 49 CFR 178.608, OSHA 1910.1030. Non-sterile, single-use.

Indications for Use

Indicated for safe disposal of hazardous sharps (needles, syringes, lancets) by qualified personnel in health care facilities or other settings where sharps are used. Not for patient contact or 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 (MA1112) (K222905)
• Maxcon Sharps Container (MA1221) (K180984)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 22, 2025

Zhejiang Gongdong Medical Technology Co., Ltd
Jingxiang Zhang
Quality Director
No 10 & 39, Beiyuan Ave.
No. 88 Jingxian Rd Huangyan
Taizhou, Zhejiang 318020
China

Re: K253222
Trade/Device Name: Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: MMK
Dated: September 28, 2025
Received: September 29, 2025

Dear Jingxiang Zhang:

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 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253222 - Jingxiang Zhang
Page 2

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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 systems (QS) regulation (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 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-

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K253222 - Jingxiang Zhang
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

STEPHEN A. DICTATE
ANISKO -S
Digitally signed by
STEPHEN A. ANISKO -S
Date: 2025.12.22
15:54:07 -05'00'

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 [phone]
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) K253222 | |
| Device Name Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | |
| Indications for Use (Describe) Gongdong sharps Containers (SCR-01Q, SCR-01G, SCR-03G) 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. 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 [e-mail] | |
| "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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K253222 510(k) Summary
Page 1 of 8

510(k) Summary

The assigned 510(k) number is: K253222
Prepared By Date: December 22, 2025

A: Applicant:

Company: Zhejiang Gongdong Medical Technology Co., Ltd

Address: A) No 10 & 39, Beiyuan Ave.
B) No.88 Jingxian Rd. Huangyan
TAIZHOU Zhejiang, CN 318020

Company Contact Person: Jingxiang Zhang

Position: Quality Director

Phone: [phone]
Email: [e-mail]
Establishment Registration: 3005739529

B. Device:

Device Common Name: Sharps Container

Device Trade/Proprietary Name: Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
Classification Regulation: 21 CFR 880.5570
Classification Name: Hypodermic Single Lumen Needle
Device Classification: Class II
Device Product Code: MMK
Review Panel: General Hospital

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K253222 510(k) Summary
Page 2 of 8

C. Predicate Device:

| Manufacturer | Device Name | Trade Name | 510(k) Number |
| --- | --- | --- | --- |
| Ningbo Maxcon Medical Technology Co., Ltd | Sharps Container | Maxcon Sharps Container (MA1112) | K222905 |
| Ningbo Maxcon Medical Technology Co., Ltd | Sharps Container | Maxcon Sharps Container (MA1221) | K180984 |

D. Indications for Use:

Gongdong sharps Containers (SCR-01Q, SCR-01G, SCR-03G) 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. 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.

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Table 1: Specification of Sharps Container

| Item# | Dimensions of the device model(L x W x H) mm | Colors available for the model | Materials | Description and dimensions of the sharps disposal aperture(s) mm | Special | | | Requirements for mounting | Weight (empty) gram | Allowable gross weight in Kg | Capacity (total) | Capacity (full line) | Acceptable sites of use (patient access) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | Locking mechanism | Needle unwinders | Recapper | | | | | | |
| SCR-01Q | 108*101*154 | Red barrel, translucent lid | Lid: Polypropylene Barrel: Polypropylene | Opening 1: 41*31 Opening 2: φ19 | Hinged closure | yes | yes | Holder with Double face adhesive tape, Free standing | lid: 24±5 barrel: 82±8 | 0.87kg | 1 QUART | 0.581 QUART | 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. |
| SCR-01G | 254*176*122 | Red barrel, translucent lid | Lid: Polypropylene Barrel: Polypropylene | 204*29.5 | folding door | no | no | Locking wall bracket | lid: 92±8 barrel: 167±10 | 3.8kg | 1 GAL | 0.77 GAL | |
| SCR-03G | 336*151*341 | Red barrel, translucent lid | Lid: Polypropylene Barrel: Polypropylene | 204*29.5 | folding door | no | no | Locking wall bracket | lid: 105±8 barrel: 455±10 | 11.9kg | 3 GAL | 2.06 GAL | |

K253222 510(k) Summary
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# E. Device Description:

Gongdong sharps container (SCR-01Q, SCR-01G, SCR-03G) are used to collect hazardous sharps such as needles, syringes, lancets and etc. The containers are single-use, disposable, non-sterile containers.

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

Table 2: Comparison of the Proposed and Predicate Device

| Characteristic | Submitted Subject Device | Predicate Device | Second Predicate Device | Comparison |
| --- | --- | --- | --- | --- |
| 510(k) | | K222905 | K180984 | N/A |
| Device Name | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Maxcon Sharps container | Maxcon Sharps Container | N/A |
| Product code | MMK | MMK | MMK | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | II | same |
| Indications for Use | Gongdong sharps containers (SCR-01Q, SCR-01G, SCR-03G) 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. 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 (1 QT Sharps Container, MA1112) 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 (2 G Sharp Container MA1221) 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. | same |
| Size | 1 Quart (SCR-01Q)1 Gallon (SCR-01G)3 Gallon (SCR-03G) | 1 Quart (MA1112) | 2 Gallon (MA1221) | similar |
| Dimensions (mm) | 108*101*154 (SCR-01Q)254*176*122 (SCR-01G) | 101.82*108.31*154(MA1112) | 316x152x230 (MA1221) | different |
| (L x W x H) | 336*151*341 (SCR-03G) | | | |

K253222 510(k) Summary

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| Single or re-usable use | Single use/disposable | Single use/disposable | Single use/disposable | Same |
| --- | --- | --- | --- | --- |
| Weight | 106g (SCR-01Q)
259g (SCR-01G)
560g (SCR-03G) | 90.6g (MA1112) | 421g (MA1221) | Different |
| No. of Pieces | 2 | 2 | 2 | Same |
| Sterile or not | Non-sterile | Non-sterile | Non-sterile | Same |
| Material | Poly-propylene (P.P) | Poly-propylene (P.P) | Poly-propylene (P.P) | same |
| Body Color | Red base,
Translucent lid | Red base,
Translucent lid | Red base,
Translucent lid | Same |
| Clarity | Opaque/translucent | Opaque/translucent | Opaque/translucent | Same |
| Method of Manufacture | Injection Molded | Injection Molded | Injection Molded | Same |
| Performance testing (puncture, impact, drop, stability, integrity) | Pass | Pass | Pass | Same |
| Standards | ISO23907-1:2019 | ISO23907-1:2019 | ASTM F2132 -01(2008)
ISO23907:2012 | Same |
| Lid configurations | Opening hinge (SCR-01Q)
Folding door (SCR-01G)
Folding door (SCR-03G) | Opening hinge (MA1112) | Folding door (MA1221) | Same |
| Accessories | Holder with Double face
Adhesive tape, Free standing (SCR-01Q)
Locking wall bracket (SCR-01G)
Locking wall bracket (SCR-03G) | Holder (made of P.P)
with Double face
adhesive tape is available
for use with 1 quart
container (MA1112) in
locking on desk top by
double face adhesive
tape. | Free standing or bracket | similar |

## Summary of technological characteristics

Gongdong sharps containers (SCR-01Q, SCR-01G, SCR-03G) have the following indications for use and technological characteristics as compared to the predicate device.:

1) The same indication for use, and targeted population, and similar site of 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: Opening hinge, folding door.

All containers can be successfully passed through the same test items (i.e. Container Stability, Strength of Handle, Resistance to penetration and Resistance to Damage and leakage after dropping and Resistance to Damage and leakage after toppling as described in ISO23907-1:2019). Although the subject device and predicate device are similar on container size & accessories; are differ on dimensions & weight, the differences in technological characteristics do not impair the subject devices from their intended functions of disposal and storage of sharp waste.

## G. Non-Clinical Performance Testing:

Performance testing were performed to validate and verify that Gongdong sharps container met

K253222 510(k) Summary

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all the requirements of related international standards and product specifications. Results of these tests demonstrate the device meets the acceptance criteria of these standards.

Table 3: Non-Clinical Performance Testing

| NO. | Test Item | Test Standards Referred | Testing Purpose | Acceptance Criteria | Test Results |
| --- | --- | --- | --- | --- | --- |
| 1 | Container Stability | ISO23907-1:2019 | Prevent the product from dumping during use. | The container shall not topple over when tested | Passed |
| 2 | Strength of Handles | ISO23907-1:2019 | Prevent the handle from breaking or separating during use. | The handle/carrying feature shall not break or detach during testing | Passed |
| 3 | Resistance To penetration | ISO23907-1:2019 | Prevent the sharps in the container from penetrating the side and bottom of the container and hurting the user. | The force needed to penetrate test specimens of the container shall be a minimum of 16N and an average of 18N or greater | Passed |
| 4 | Resistance To damage And leakage After dropping | ISO23907-1:2019 | Prevent the container from breaking when falling from a height, and the sharps leak from the container. | There shall be no evidence of leakage and no breach of the sharps containment area after tested | Passed |
| 5 | Resistance To damage And leakage After toppling | ISO23907-1:2019 | Prevent the container from breaking when toppling, and the sharps leak from the container. | There shall be no evidence of leakage and no breach of the sharps containment area after tested | Passed |

K253222 510(k) Summary
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| 6 | Stacking Test | 49CFR 178.606 | The container will not be damaged during storage and shipping while stacking. | No test sample may leak. No test sample may show any deterioration which could adversely affect transportation safety or any distortion likely to reduce its strength, cause instability in stacks of packages, or cause damage to inner packaging likely to reduce safety in transportation. | Passed |
| --- | --- | --- | --- | --- | --- |
| 7 | Vibration Test | 49CFR 178.608 | Packaging cartons and products will not be damaged due to product transportation vibration | There is no rupture or leakage from any of the packages. No test sample should show any deterioration which could adversely affect transportation safety or any distortion liable to reduce packaging strength. | Passed |
| 8 | Sharps access and closure for repeated openings and closings | Manufacturer's internal testing SOP | Ensure the access and closure at lid are functioning well during use. | After the simulated time of Sharps access and closure for repeated openings and closings of the Sharps containers, all locking mechanism of the samples should be of no malfunction, and should lock sharps container permanently and securely | Passed |
| 9 | Usable Capacity Test | Manufacturer's internal testing SOP | Ensure the container loading volumes are within designed specs. | The difference between the measured capacity volume and designed capacity should be within ±3%. | Passed |
| 10 | Leak Proof on the sides and bottom | OSHA Regulations (Standards - 29 CFR) Bloodborne Pathogens. 1910.1030, (d)(2)(viii)(C) | Ensure the barrel integrity. | leak proof on the sides and bottom | Passed |

Clinical Testing: Not Applicable

K253222 510(k) Summary
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K253222 510(k) Summary
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## 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 (K222905 & K180984).