Sharps Container
by Custom Medical Plastics, Inc. 510(k)
Active
510(k) K970398
Overview
The Sharps Container is a medical device classified as a Sharps Disposal Container (FDA Product Code: FMI). It is designed to safely and securely contain used, contaminated sharps—such as needles, syringes, and scalpels—to prevent accidental sticks, cuts, and exposure to biohazardous materials. Constructed from durable plastic, it provides a puncture-resistant enclosure to mitigate risks during handling and disposal.
This device is intended for single-use in healthcare settings, including hospitals and clinics, where sharps are generated. Supplied in a sterile or non-sterile form depending on the model, it must be disposed of after use in accordance with local hazardous waste regulations. The container is approved under FDA 510(k) clearance (K970398) and adheres to traditional review standards. No MRI safety or reusable designations are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970398 | Date3 Jul 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Custom Medical Plastics, Inc.
Questions
What is the Sharps Container designed for?
The Sharps Container is specifically engineered to safely and securely contain used, contaminated sharps such as needles, syringes, and scalpels. Its puncture-resistant plastic design prevents accidental sticks, cuts, and exposure to biohazardous materials, ensuring safe handling and disposal in healthcare environments like hospitals and clinics.
Is the Sharps Container sterile or non-sterile?
The Sharps Container is available in both sterile and non-sterile versions, depending on the model. Sterility is important in clinical settings where contamination risks must be minimized, while non-sterile versions may be suitable for less critical applications. Always verify the specific model’s sterility status before use.
Can the Sharps Container be reused?
No, the Sharps Container is intended for single-use only. After use, it must be disposed of in accordance with local hazardous waste regulations to prevent contamination and ensure compliance with safety protocols. Reuse could compromise its integrity and pose risks to healthcare workers.
What are the key safety features of this container?
The Sharps Container’s primary safety features include its durable, puncture-resistant plastic construction, which prevents accidental injuries from sharps during handling or disposal. Its sealed design also minimizes the risk of biohazard exposure, making it a critical tool for infection control in medical settings.
How should the Sharps Container be disposed of after use?
After use, the Sharps Container must be sealed securely and disposed of as hazardous waste in compliance with local, state, and federal regulations. Never recap or bend used sharps inside the container, as this can increase injury risks. Follow your facility’s established protocols for sharps disposal to ensure safety and regulatory adherence.