Product Overview
Our hydrogel gauze wound dressing is a sterile, single-use primary contact layer composed of a soft medical-grade gauze substrate evenly impregnated with an amorphous hydrogel formulation containing carbomer, triethanolamine, and vitamin E. Specifically developed for dry, minimally draining, and sloughy wounds, this hydrogel gauze wound dressing continuously delivers moisture to non-viable tissue to support natural autolytic debridement while maintaining a balanced moist interface that prevents secondary dressing adherence and protects fragile granulating tissue.
Products Description
| Item | Specification |
|---|---|
| Product Name | Hydrogel Gauze Wound Dressing (Sterile Hydrogel Impregnated Gauze) |
| Dressing Type | Hydrogel Impregnated Gauze Dressing / Moisture-Donating Primary Contact Dressing |
| Base Material / Active Ingredient | Medical-grade absorbent gauze substrate impregnated with formulated hydrogel (purified water, carbomer, triethanolamine, vitamin E) |
| Sterility | Sterile (Single-use disposable) |
| Material Structure | Viscosity: 7,000–30,000 mPa·s (25±2°C); Loading deviation: ±2.0 g; Heavy metal content: ≤ 10 ppm; Chemical pH: 5.0–8.0; Appearance: Uniform light yellow or translucent gel coating without granular impurities |
| Packaging | Individually sealed sterile barrier peel pouch; 10 pouches per dispenser carton; master shipping boxes |
| Sterilization Method | Ethylene Oxide (EO) Sterilization / Gamma Irradiation (To be confirmed) |
| Shelf Life | 3 Years |
| Storage Condition | Store in a cool, ventilated, and dry room under normal ambient temperature; protect from direct heat, sunlight, and freezing conditions |
| OEM / ODM Support | Supported (Custom dimensions, customized gel loading volume, custom foil pouch printing, private labeling) |
Key Features
High-viscosity hydrogel formulation (7,000–30,000 mPa·s) – helps maintain gel cohesion on the gauze weave, reducing gel run-off and maintaining steady local moisture donation.
Active moisture-donating mechanism – helps rehydrate dry necrotic eschar and soften fibrinous slough, facilitating natural autolytic debridement without mechanical tissue trauma.
Soft woven gauze carrier – conforms easily to irregular wound cavities and uneven anatomical contours, providing structural integrity during clinical application.
Non-adherent interface barrier – prevents dry gauze filaments from embedding into newly formed granulation tissue, helping facilitate atraumatic dressing changes.
Balanced biocompatible pH range (5.0–8.0) – helps preserve an optimal biochemical microenvironment aligned with the natural cutaneous barrier.
Vitamin E incorporated matrix – helps soothe surrounding wound margins and provides structural stability to the hydrogel emulsion throughout application.
Hydration-assisted removal capability – allows clinicians to rehydrate the dressing with sterile saline if dryness occurs, helping protect delicate newly formed epithelial cells upon peeling.
Single-dose sterile peel packaging – helps minimize potential clinical cross-contamination between patient applications and preserves shelf stability.
Indications & Applications
Clinical Indications
- The hydrogel gauze wound dressing is indicated as a primary wound contact layer for low-exudate, dry, or slough-covered partial- and full-thickness wounds:
- Pressure Injuries: Suitable for Stage II, Stage III, and Stage IV pressure ulcers presenting with minimal exudate or hardened necrotic tissue requiring autolysis.
- Diabetic Lower-Extremity Ulcers: Delivers regulated hydration to dry neuropathic and neuroischemic wound beds to encourage granulation tissue formation.
- Skin Tears & Superficial Trauma: Provides a moist protective cover over fragile epidermal tissue tears, clean cuts, and minor donor sites.
- Post-Operative Surgical Sites: Covers clean, low-draining post-surgical incisions and closed incision lines to prevent desiccation.
- Necrotic & Sloughy Wounds: Softens thick eschar and devitalized cellular debris prior to secondary clinical assessment.
Sizes & Packaging Details
(B2B Procurement & Channel Distribution Specifications)
| Dressing Size (cm / in) | Gel Loading Weight (g) | Dressings per Pouch | Pouches per Box | Boxes per Carton |
|---|---|---|---|---|
| 5 cm x 5 cm (2" x 2") | 8g ± 2g | 1 pc | 10 pcs | 20 boxes |
| 10 cm x 10 cm (4" x 4") | 25g ± 2g | 1 pc | 10 pcs | 20 boxes |
| 10 cm x 12.5 cm (4" x 5") | 28g ± 2g | 1 pc | 10 pcs | 20 boxes |
Commercial OEM & Distribution Packaging
- Barrier Pouch Integrity: High-barrier medical peel pouches designed to preserve water content, gel viscosity, and seal hermeticity throughout the 3-year shelf life.
- Secondary Packaging: 10-count shelf dispenser cartons printed with GS1 DataMatrix barcodes, lot numbering, sterility indicators, and multi-language user warnings.
- Wholesale Bulk Customization: Support for custom gel formulation loading (grams per unit area), alternative substrate mesh dimensions, and customer-branded outer shipping cases.
Quality & Regulatory Information
- ISO 13485:2016 Certified: Manufactured under an audited medical device quality management system covering sterile processing and gel formulation.
- U.S. FDA Listed: Meets regulatory criteria under 21 CFR device classification for sterile hydrogel wound dressings.
- Viscosity Standard Verification: Every batch tested at 25±2°C to comply with the 7,000–30,000 mPa·s range for clinical spreadability and cohesion.
- Physicochemical Purity: Documented testing verifies heavy metal limits at ≤ 10 ppm and finished matrix pH maintained strictly between 5.0 and 8.0.
- Sterility Assurance: Validated terminal sterilization protocol ensuring a Sterility Assurance Level (SAL) of 10⁻⁶.
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