[Production License Number] Sujiang Medical Device Production License No. 20240191
[Product Registration Certificate Number] Su Medical Device Registration No. 20252022195
[Product Technical Requirements Number] Su Medical Device Registration No. 20252022195
[Product Name] Single-use skin preparation kit
【Model Specifications】 Single-blade type, double-blade type
【Structural Composition】
Single-use skin-preparation kits are available in two configurations—single-blade and double-blade—depending on the design of the skin-preparation blade. Each kit includes a basic configuration consisting of a single-use skin-preparation blade, single-use film gloves, and optional components such as dressing pads, wrapping cloth, a tray, an antiseptic brush, mild soap, forceps, and cotton balls. The product is supplied in a sterile condition, sterilized with ethylene oxide, and intended for single use only.
【Product Performance】
Ethylene oxide residue: ≤10 μg/g.
Basic Configuration of a Single-Use Skin Preparation Kit
| Serial Number |
Component Name |
Specifications |
Quantity |
Remarks |
|
| 1 |
Basic Configuration |
Single-use skin preparation blade |
Single-blade type/Double-blade type |
1–2 pieces |
Outsourced/Record Filing Certificate |
| 2 |
Single-use thin film gloves |
Large, medium, small |
1–3 copies |
Outsourced/Record Filing Certificate |
|
| 3 |
Selection and formulation |
Disinfection brush |
Square-shaped |
1 only |
Outsourced/Record Filing Certificate |
| 4 |
Dressing sheet |
(20–200) × (20–200) mm ±10% |
1–5 pieces |
Outsourcing |
|
| 5 |
Soft soap |
≥2g/bag |
1 bag |
Outsourcing |
|
| 6 |
Cloth wrapping |
(200–600) × (300–800) mm ±10% |
1 piece |
Outsourcing |
|
| Tweezers |
≥100mm |
1–2 pieces |
Outsourced/Registration Certificate |
||
| Cotton ball |
≥0.1 g per individual |
1–20 pieces |
Outsourced/Record Filing Certificate |
||
| 7 |
Tray |
Waist plate/square plate |
1 only |
Outsourcing |
|
【Scope of Application】 For preoperative skin preparation in clinical surgical procedures.
【Contraindications】 Do not use if you are allergic to the product’s ingredients.
Keywords:
Single-use skin preparation kit
Single-use skin preparation kit
Hotline consultation
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