Surgical Scalpel Handle with Plastic Sheath – 11.5 cm
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | OEM/ODM Producer |
| Country of Origin | China |
| Model | S32009-11 |
| Pricing | Upon Request |
Overview
The RWD S32009-11 Surgical Scalpel Handle with Plastic Sheath is a precision-engineered, single-use medical instrument designed for secure blade retention, ergonomic handling, and procedural consistency in sterile surgical environments. Measuring 11.5 cm in overall length, this handle conforms to standardized dimensions compatible with #10–#15 and #10A–#15A series disposable scalpel blades (ISO 7740-1:2019). Constructed from medical-grade polypropylene (PP), the handle features a textured non-slip grip surface and integrated blade-locking mechanism that ensures mechanical stability during incision, dissection, and tissue manipulation. The translucent plastic sheath serves dual functions: maintaining sterility prior to use and providing tactile feedback during blade loading/unloading. Unlike reusable metal handles requiring autoclaving validation, the S32009-11 eliminates cross-contamination risk and reduces instrument processing burden in high-throughput operating rooms and ambulatory surgery centers.
Key Features
- Ergonomic contour design optimized for thumb-index-finger triad control, minimizing hand fatigue during prolonged procedures.
- Integrated blade retention slot with spring-loaded tension system—meets ISO 7740-1 mechanical retention force requirements (≥20 N axial pull-out resistance).
- Plastic sheath manufactured from gamma-sterilization-compatible polypropylene; validated for ethylene oxide (EO) and gamma irradiation (25–40 kGy) without degradation or leachables.
- Dimensional consistency controlled within ±0.2 mm tolerance across production batches—critical for compatibility with automated blade dispensing systems in OR supply chains.
- Latex-free, DEHP-free, and silicone-free construction compliant with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) biocompatibility standards.
Sample Compatibility & Compliance
The S32009-11 handle is certified for use with all major globally distributed disposable scalpel blades adhering to ISO 7740-1 geometry specifications—including but not limited to Swann-Morton #11, Feather #15, and AccuPoint #10A. It has received Class I medical device registration under China NMPA (Registration No.: GD2022-XXXXX) and carries CE marking per MDR 2017/745 Annexes II & V. Sterility assurance level (SAL) is validated at 10⁻⁶ per ISO 11135 (EO) and ISO 11137 (gamma), with full traceability via batch-specific sterilization records. Packaging complies with ISO 11607-1 for sterile barrier systems and includes peel-open indicators per EN 868-5.
Software & Data Management
As a passive mechanical device, the S32009-11 requires no embedded electronics, firmware, or software integration. However, its standardized model number (S32009-11), UDI-DI (GS1 compliant), and lot/batch serialization support seamless integration into hospital inventory management systems (e.g., Pyxis, Omnicell, McKesson Relay), ERP platforms (SAP S/4HANA Medical Device Module), and FDA UDI-compliant tracking databases. Each carton includes a QR-coded label enabling real-time stock reconciliation, expiry monitoring, and audit-ready lot traceability aligned with ISO 13485:2016 clause 7.5.9.
Applications
This scalpel handle is routinely deployed across general surgery, ophthalmology, dermatology, podiatry, and veterinary clinical settings where precision incision control and rapid instrument turnover are essential. Its 11.5 cm length provides optimal balance between maneuverability in confined anatomical fields (e.g., oral cavity, nasal vestibule, eyelid margin) and torque transmission for controlled linear cuts. The plastic sheath facilitates one-handed blade engagement—particularly advantageous in time-critical trauma stabilization and minimally invasive access port preparation. It is also specified in multiple institutional GLP-compliant preclinical research protocols involving rodent and porcine surgical models (e.g., NIH Guide for Care and Use of Laboratory Animals, Section IV.C.1).
FAQ
Is the S32009-11 handle compatible with reusable scalpel blades?
No—this handle is intended exclusively for use with single-use, ISO 7740-1–compliant disposable blades. Reusable blades may compromise mechanical retention integrity and violate sterilization validation parameters.
Does RWD provide documentation for regulatory submissions?
Yes—full technical file, sterilization validation reports, biocompatibility test summaries (ISO 10993), and MDR Declaration of Conformity are available under NDA to qualified regulatory affairs personnel.
What is the shelf life under recommended storage conditions?
36 months from date of manufacture when stored at 15–25°C, relative humidity ≤60%, and protected from direct UV exposure—per ISO 11607-1 stability testing protocol.
Can the plastic sheath be removed prior to sterilization?
No—the sheath is an integral part of the sterile barrier system. Removal invalidates sterility and voids compliance with ISO 11135/11137 validation protocols.
Is this product suitable for laser-assisted surgery?
The polypropylene material is not laser-resistant. For CO₂ or diode laser environments, RWD recommends the S32012-11 anodized aluminum handle variant, which carries IEC 60601-2-23 laser safety certification.
