Disposable Nitrile Examination Gloves
by Jiangxi Handspro Products Solutions Co., Ltd EUDAMED510(k)
Active
510(k) K223004
Overview
The Disposable Nitrile Examination Gloves are classified as a disposable glove (product code LZA) designed for single-use in clinical and general hospital settings. Constructed from nitrile, these gloves provide a chemical-resistant barrier to protect both the wearer and patient during examinations, procedures, or medical interventions requiring aseptic conditions.
These gloves are supplied in sterile, disposable packaging for immediate single-use and comply with FDA 510(k) clearance (K223004) and EU MDR regulations. They are intended for general hospital use and are not reusable; proper disposal follows each use. No MRI safety information is specified, and sizes are not detailed in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK223004 | Date4 Dec 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LZA
- FDA applicant
- Jiangxi Handspro Products Solutions Co., Ltd.
- Device Class
- Class I
- Regulation
- 21 CFR Part 880.6250
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
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Questions
Are these gloves suitable for use in MRI environments, and if not, why not?
The provided data does not specify any MRI safety information for these gloves, meaning they are not explicitly labeled or tested for safe use in MRI environments. Since MRI requires materials that do not interfere with magnetic fields, and no such details are mentioned, these gloves should not be assumed safe for MRI procedures. Always verify compatibility with your facility’s MRI guidelines before use.
How should I store these gloves to maintain their sterility and usability?
These gloves are supplied in sterile, disposable packaging designed for single-use. To preserve sterility, store them in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Avoid opening the packaging until immediate use, as the barrier is intended to remain intact until the gloves are donned.
Can these gloves be reused, and if not, what happens if they are?
These gloves are explicitly designed for single-use only and are not intended for reuse. Reusing them compromises the chemical-resistant barrier and may pose risks to both the wearer and patient, including potential contamination or glove degradation. Proper disposal after each use is required to comply with clinical and regulatory standards.
What regulatory pathways have these gloves followed, and how does that affect their use?
These gloves have undergone FDA 510(k) clearance (K223004) under the traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device, and comply with EU MDR regulations. This means they meet U.S. and EU standards for safety and performance as a disposable glove (product code LZA) for general hospital use, ensuring they can be legally marketed and used in those regions without additional restrictions beyond standard clinical guidelines.