LucentMed operates four major manufacturing facilities featuring 7,800 square meters of cleanroom space and is a dedicated manufacturer and supplier of sterile gynecological sampling brushes. Our products undergo ethylene oxide (EO) sterilization and are individually packaged in strict accordance with ISO 11135 standards; every batch is validated using biological indicators. We welcome inquiries regarding samples.
LucentMed is a specialized manufacturer of sterile gynecological sampling brushes; we operate our own factory, possess over 20 years of industry experience, and employ a team of more than 160 people.
Our sampling brushes feature soft, shed-resistant bristles and a secure connection between the brush head and the shaft, and they come with a three-year quality guarantee.
Why Do Gynecological Sampling Brushes Need to Be Sterile?
1. Reducing the risk of cross-infection
Gynecological sampling is an invasive or semi-invasive medical procedure requiring direct contact with the cervix or vaginal mucosa.
Using a sterile gynecological sampling brush effectively lowers the risk of microbial transmission and minimizes cross-contamination, thereby meeting hospital infection control standards.
2. Maintaining sample purity
Sterile sampling tools help reduce exogenous contamination during liquid-based cytology (LBC) and other cytological tests, ensuring the collected cell samples better meet testing requirements.
3. Compliance with modern infection control standards
Hospitals, maternal and child health centers, health check-up centers, and medical laboratories worldwide generally have strict requirements for disposable sterile medical devices. Sterile sampling brushes meet clinical procedural standards, facilitating the establishment of standardized sampling workflows within medical institutions.
4. Enhancing patient safety
These products undergo sterilization after manufacturing and are sealed in medical-grade packaging. This minimizes potential risks associated with device contamination during sampling, ensuring greater safety for patients throughout the standardized procedure.
Product Specifications
Parameter Category
Wire Type
Primary Material
Bristles: Nylon filaments wound with stainless steel wire
Tip bead: Epoxy resin (on select models)
Common Specifications
A1, A2, A3, A4, etc.
Brush Head Design
Broom-like or spiral shape; utilizes wire elasticity to conform to the shape of the cervix
Total Length
Typically 140mm – 170mm, depending on handle design
Sterilization Method
Ethylene oxide (EO) sterilization
Residual Limit Standard
Residual ethylene oxide ≤ 10µg/g
Scope of Application
Intended for endocervical cell collection and vaginal secretion sampling; certain designs facilitate deeper access into the cervical canal
Recommendations for Different Testing Methods
Testing Methods
Product Applications
Usage Recommendations
Liquid-based cytology (LBC)
Cervical cancer screening and cytology testing
After sampling, promptly place the brush head into the designated cell preservation solution to ensure the collected cells are fully released, and store and transport the sample in accordance with laboratory requirements.
Pap smear
Routine cervical cytology examination
After sampling, transfer the cells evenly onto a microscope slide as soon as possible and proceed with fixation and subsequent processing according to laboratory protocols to minimize the impact of cell drying on sample quality.
HPV co-testing
HPV testing combined with cytology
If performing combined screening, follow the sampling procedures specified for the test kit or by the medical institution to ensure that sample requirements for the various tests are met.
Routine gynecological cytology
Gynecology clinics and health check-up centers
Select the appropriate sample processing method based on the specific test and submit the sample for analysis promptly to avoid compromising sample quality due to improper storage.
LucentMed Quality Management
1. Carefully Selected Medical-Grade Raw Materials
Our Sterile Gynecological Sampling Brushes are manufactured using raw materials that meet medical device requirements. All materials undergo rigorous screening and quality inspection to ensure consistent quality and full traceability.
2. Standardized Production Processes and Quality Testing
LucentMed implements strict controls across every stage of production—including molding, assembly, and packaging—and maintains comprehensive records of the manufacturing process.
Each batch undergoes rigorous quality testing, including thorough inspections of appearance, dimensions, assembly quality, and packaging integrity, to ensure compliance with customer requirements and relevant quality standards.
3. Meeting International Quality Requirements
With over 20 years of manufacturing experience, we support OEM/ODM services. We provide the necessary product quality documentation and technical support to meet the market requirements of different countries and regions, helping clients successfully manage their brands and engage in international trade.
Support includes:
ISO 13485 Quality Management System
ISO 9001 Quality Management System
CE technical documentation support (where applicable)
Product technical specifications and testing reports
OEM/ODM quality control support
FAQ
Q1: How is the sterility of the disposable sterile cervical brush ensured? What is its shelf life?
A: The product is manufactured in a Class 100,000 cleanroom, sterilized using ethylene oxide (EO), and individually packaged in paper-plastic or blister packs.
A sterilization validation report is provided for each batch. The shelf life is 3 years; use is strictly prohibited if the product is expired or the packaging is damaged.
Q2: How should the brush head be handled after sampling? Can it be reused?
A: After sampling, the brush head can be snapped off at the pre-set break point on the handle. This product is for single use only; reuse is strictly prohibited, and it must be disposed of as medical waste after use.
Q3: Can the Sterile Gynecological Sampling Brush be used for self-sampling at home?
A: Yes, but it requires the use of a dedicated preservation solution and testing service, and the procedure should be performed under the guidance of a physician or professional.
Q4: Does the product hold relevant certifications? How is quality ensured?
A: LucentMed has obtained ISO 13485 certification for medical device quality management systems and has completed the filing for Class I medical device manufacturing.
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