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The 304 grade surgical needle from Shanxian Runte Medical Instruments Co., Ltd is a U.S.P standard suture needle manufactured from AISI 304 stainless steel, an austenitic alloy selected for surgical instruments due to its non-magnetic properties, ease of cold working to extreme sharpness, and corrosion resistance in sterile environments. The needles are produced in assorted sizes and types to accommodate tissue-specific suturing requirements, with each box containing 12 pieces. The 304 grade provides sufficient hardness after cold working for needle points and bodies, though some premium surgical needles use 420 or 455 martensitic stainless for higher hardness in heavy-duty applications.
U.S.P standard classification governs needle dimensions, curvature, and point geometry, with common curvatures including 1/4 circle, 3/8 circle, 1/2 circle, 5/8 circle, and straight, and point types ranging from taper point (round body) for soft tissue to cutting point (triangular cross-section with cutting edges) for skin and tough fascia. The 304 stainless steel body is typically drawn to wire, then formed to curvature, heat-treated for stress relief, and electropolished to create a smooth surface that minimizes tissue drag and bacterial adhesion. Siliconization is often applied as a final coating to reduce frictional resistance during passage through tissue, though this must be biocompatible and non-pyrogenic per ISO 10993.
Primary end users include hospital operating theatres, outpatient surgical clinics, veterinary practices, and dental surgery centers. The needles are supplied non-sterile for in-house sterilization or may be offered sterile-packaged depending on configuration. When importing from Shandong Province, buyers should verify CE marking or FDA 510(k) status if marketing in regulated jurisdictions, and confirm whether the 304 grade is certified to ASTM F899 or equivalent surgical material standard. The U.S.P designation indicates conformance to United States Pharmacopeia dimensional and performance standards, which many national regulatory systems reference or recognize.
| Material Grade | AISI 304 stainless steel, U.S.P standard |
| Needle Curvature | 1/4, 3/8, 1/2, 5/8 circle, or straight, standard range |
| Point Geometry | Taper point, cutting, or reverse cutting, standard |
| Surface Finish | Electropolished, typical; siliconized optional |
| Sterility | Non-sterile (typical) or sterile, confirm with supplier |
| Packaging | 12 pieces per box, confirm configuration |
| Corrosion Resistance | Resistant to sterilization cycles, standard for 304 surgical grade |
| Magnetic Response | Non-magnetic in annealed condition, typical for 304 |
| Hardness | Cold-worked to needle application requirements, confirm HRC |
| Regulatory Standard | U.S.P (United States Pharmacopeia), stated |
Shanxian Runte Medical Instruments Co., Ltd is located at No.22 Shidaihuayuan, Wenhua Road, Shanxian, Heze 274300, Shandong Province, China. The company holds both Imported supplier tier and Harbor trust tier designations on the platform, with a response rate showing 0.00% and zero recorded average response hours, indicating no quantified inquiry responsiveness. The Shandong location places it within a province with emerging medical device manufacturing activity, though less concentrated than Jiangsu or Zhejiang medical device clusters.
The supplier profile provides no verified information regarding manufacturing facility size, ISO 13485 medical device quality management certification, FDA registration number, or named hospital or distributor clientele. The source description references U.S.P standard and 304 grade material, but buyers must independently verify material certification, sterility assurance level if applicable, and any claimed international medical standards compliance. The company's capacity for custom needle configurations, such as proprietary curvatures or attached suture types, should be discussed directly with the supplier.
| Business Type | Supplier |
| Year Established | Recently Joined |
| Employees | Contact Supplier |
| Annual Revenue | Contact Supplier |
| Main Products | View Products Tab |
| Major Markets | Global |
| Response Time | <4h |
| Response Rate | New Supplier |
Before committing to an order with Shanxian Runte Medical Instruments Co., Ltd, verify the company's medical device manufacturing license and any quality system registration. Request samples of the specific needle curvatures and point types required, and evaluate these for point sharpness consistency, body straightness, and surface finish under magnification. Conduct material verification through XRF analysis or request mill certificates with heat lot traceability. For sterile product, review the sterilization subcontractor's qualifications and whether the supplier maintains environmental monitoring records for cleanroom or controlled manufacturing areas. Establish whether the company has prior export experience to your target regulatory jurisdiction.
Logistics from Heze in Shandong Province typically route through Qingdao Port for sea freight, with land transport of approximately 300-400 kilometers. Confirm Incoterms, as the supplier may quote EXW Heze or FOB Qingdao. Payment structures for initial medical device orders often involve documentary letters of credit or advance payment with balance against shipping documents, though terms should reflect any verified trade history. Lead times are not stated and must be confirmed in writing, with typical surgical needle production requiring 30-60 days depending on customization and sterilization scheduling. Request detailed packing specifications including inner box quantities, master carton dimensions, and gross weight for freight cost estimation.
Quality assurance for surgical needles should include dimensional inspection against U.S.P standards using optical comparators or calibrated microscopes, bend testing for body ductility, and surface examination for defects or contamination. For regulatory compliance, engage a third-party inspection agency to verify manufacturing conditions and documentation authenticity. Request batch release records, raw material certificates, and any available sterilization validation data. For imported medical devices, confirm your obligations as importer of record for registration, customs classification under HS code 9018.32, and post-market surveillance reporting. Establish a protocol for handling adverse events or product recalls, including the supplier's commitment to notification and investigation timelines.
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Securing a reliable supply chain for 304 Grade Surgical Needle is critical for maintaining your business operations. Shanxian Runte Medical Instruments Co., Ltd., a verified supplier located in China, provides high-quality 304 Grade Surgical Needle ready for international export. By connecting directly with this supplier, buyers can bypass intermediaries, negotiate custom wholesale pricing, and arrange bulk shipments. This product is a key offering within the Medical Needles & IV Cannula industry, catering to distributors, wholesalers, and importers worldwide.
Navigating the complexities of global sourcing is easier when you have direct access to the right manufacturers and exporters. When importing 304 Grade Surgical Needle from China, buyers can discuss shipping logistics, packaging requirements, and preferred payment terms directly with Shanxian Runte Medical Instruments Co., Ltd.. This seamless communication is powered by EximNext, a premier global B2B marketplace that connects ambitious buyers with verified global sellers across every major industry.
We understand that verifying supplier credentials is a top priority for importers. Shanxian Runte Medical Instruments Co., Ltd. is part of our extensive network of vetted international exporters. Browse more products in the Medical Needles & IV Cannula category or discover new suppliers across the Medical Needles & IV Cannula sector. Expand your sourcing capabilities through our trusted import export marketplace — the import export marketplace built for serious international trade.
When importing 304 Grade Surgical Needle from China, buyers should consider shipping terms (FOB, CIF, EXW), customs documentation requirements, and payment security. Contact the supplier to discuss the best logistics options for your destination country.
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