Huida Medical (JSHD) manufactures sterile scalpels with handle for operating rooms, outpatient clinics, and field medical kits worldwide. Our product line covers both reusable stainless steel scalpels and single-use disposable scalpels with permanently welded blades, available in the full clinical size range #10 through #36. Every unit is individually peel-packed and gamma-sterilized to SAL 10⁻⁶, produced in our own ISO 13485–certified factory with CE and FDA compliance.

Features Of Sterile Scalpels With Handle

Two handle systems: reusable stainless steel handle (changeable blades) and single-use plastic handle with welded blade

Two blade materials: high-carbon steel (maximum initial sharpness) and stainless steel (superior edge retention & corrosion resistance)

 Full size range: #10, #11, #12, #13, #14, #15, #18, #19, #20, #21, #22, #23, #24, #25, #36

Gamma sterilized to Sterility Assurance Level 10⁻⁶; individually sealed peel pouches

Protective safety sheath on disposable models to reduce sharps injury

ISO 13485, CE, FDA registered manufacturing

Welded blade-to-handle joint — no blade detachment during dissection

5-year shelf life under recommended storage conditions

Description Of A Sterile Scalpel With Handle

A sterile scalpel with handle is a fundamental surgical cutting instrument used to make incisions in soft tissue. Unlike surgical blades sold separately, a "with handle" scalpel arrives fully assembled and sterile, ready for immediate use — eliminating blade-mounting steps and reducing the risk of sharps injury and contamination in the operating room.

Huida Medical produces three configurations to match different clinical and economic needs:

1. Reusable Stainless Steel Scalpels

Our stainless steel scalpel handles are precision-machined for balanced grip and durable blade-fit. The blade is detachable and replaced between patients; the handle is cleaned and autoclaved for repeated use. This system is ideal for high-volume hospital ORs with established sterile processing departments, where long-term cost-per-procedure is a priority.

2. Disposable Carbon Steel Scalpels with Plastic Handle

Carbon steel delivers the sharpest initial edge. Our disposable carbon steel scalpel features a permanently welded blade-to-handle joint — the blade cannot be removed, ensuring single-use only and eliminating cross-contamination risk. A protective sheath covers the blade until use. Best for short, precise procedures: dermatology, podiatry, outpatient surgery, and emergency/field medicine.

3. Disposable Stainless Steel Scalpels with Plastic Handle

Stainless steel blades retain their edge longer and resist corrosion, making them suitable for longer procedures and facilities with less controlled storage environments. The same welded construction and protective sheath design apply.

Sterilization & Packaging

Every disposable scalpel is gamma-irradiated at 25 kGy, validated to SAL 10⁻⁶ (one-in-a-million probability of non-sterility).

Each unit is individually sealed in a peel pouch with lot number, sterilization date, and expiry date.

Standard packaging: 10 pieces per box, 100 pieces per carton — customizable for distributor private-label orders.

Shelf life: 5 years when stored in a cool, dry environment away from direct UV light.

Quality & Compliance

Huida Medical is a manufacturer, not a trading company. Our in-house production covers blade grinding, handle assembly, cleanroom packaging, and sterilization validation. We maintain:

ISO 13485:2016 Quality Management System

CE marking under EU Medical Device Regulation (MDR)

FDA registration / listing for the U.S. market

ISO 10993 biocompatibility testing

ISO 11137 sterilization validation

Full Technical File, Declaration of Conformity, and audit reports are available to procurement and regulatory teams on request.

【Applications 】

General Surgery & Operating Rooms

Dermatology & Aesthetic Clinics

Outpatient / Ambulatory Surgery Centers

Emergency Departments & Trauma Kits

Podiatry & Foot Care

ENT (Ear, Nose, Throat) Procedures

Orthopedic Surgery

Field Medicine, Military & Disaster Response

Veterinary Surgery

Medical Training & Anatomy Labs

【Why Choose Huida Medical】

Own factory — full control over raw material, production, and sterilization; no middleman markup.

Full size range in stock — #10 through #36, ready for mixed-size orders.

Material traceability — every lot traceable to steel mill certificates.

Regulatory-ready documentation — CE, FDA, ISO 13485 technical files provided for import clearance.

Flexible MOQ — sample kits for clinical evaluation, container orders for distributors.

Private label / OEM available for qualified distributors.

【FAQ】

Q: Are these scalpels sterile when delivered?

A: Yes. Disposable scalpels arrive gamma-sterilized and individually sealed. Do not use if the pouch is torn, wet, or expired.

Q: Can disposable scalpels be resterilized?

A: No. They are validated for single use only. Reprocessing compromises blade integrity and sterility.

Q: What is the difference between carbon steel and stainless steel blades?

A: Carbon steel offers the sharpest initial edge but dulls faster and is corrosion-sensitive. Stainless steel retains edge longer and resists corrosion — better for longer procedures and uncontrolled storage.

Q: Which sizes should I stock first?

A: For general supply, #10, #11, #15, #20, and #22 cover most procedures. Specialty departments add #12, #21, #23–#25, and #36.

Q: Can I get my own brand packaging?

A: Yes, Huida offers private-label / OEM packaging for qualified distributor partners. Contact us for minimums and artwork requirements.