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Laparotomy Sponge

Master Spec Matrix: BaSO₄ Content & Absorbency Rates Benchmarking clinical safety through measurable engineering tolerances and EN 14079 standards. X-Ray Opacity ≥ 55% Barium Sulfate Content […]

Regulatory CE MDR 2017/745 Standard
Quality ISO 13485 Certified System
Compliance FDA 510(k) US Market Cleared
Facility GMP Audit Production Safety
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Master Spec Matrix: BaSO₄ Content & Absorbency Rates

Benchmarking clinical safety through measurable engineering tolerances and EN 14079 standards.

X-Ray Opacity
≥ 55%

Barium Sulfate Content

Fluid Retention
8.2g / g

Absorption Efficiency

Bleaching
100%

Chlorine-Free Oxygen Tech

Compliance
MDR

EU 2017/745 Certified

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Ref. SKU Series Standard Sizes Ply & Mesh Options X-Ray (BaSO₄) Yarn Count Special Features
LS-3030-W 30 x 30 cm 4, 8, 12, 16-ply | 13, 17, 20-mesh ≥ 55% Content 21s, 32s, 40s Blue LoopSterile
LS-4545-W 45 x 45 cm 4, 6, 8-ply | 17, 20-mesh Interwoven 21s, 40s Pre-washed

* Engineering Note: Kingphar’s laparotomy sponges are engineered for zero-linting and maximum tensile strength. Custom BaSO₄ density and bespoke folding geometries are available for large-scale hospital tenders.

Gauze Engineering Matrix

Comparative Technical Specs & Dimensional Standards (MDR 2017/745)

Technical Summary: Kingphar medical gauze adheres to EN 14079:2003 standards, featuring ≥ 55% Barium Sulfate for X-ray lines and Chlorine-free oxygen bleaching. Our vertical supply chain supports custom mesh densities from 13 to 24 threads/cm².
Series SKU Standard Sizes Ply & Mesh X-Ray Tech (BaSO₄) Bleaching Process Compliance
LS-3030-Series 30 x 30 cm 12, 16-ply | 17, 20-mesh ≥ 55% Content (Max Contrast) Oxygen Bleached (H₂O₂) USP / BP / MDR
LS-4545-Series 45 x 45 cm 4, 6, 8-ply | 17-mesh Interwoven Filament Chlorine-Free CE / FDA / ISO
LS-2020-PW 20 x 20 cm 24-ply | High Density Radiopaque Loop Zero Residue EN 14079

* Vertical Integration: Kingphar manages the entire cycle from spinning to final sterilization, ensuring pH levels are maintained at 6.8 - 7.2 for optimal tissue biocompatibility.

ISO 13485 OEKO-TEX MDR Certified
Kingphar Advanced Oxygen Bleaching Facility
100% Pure Cotton Certified Chlorine-Free Process

Chlorine-Free Oxygen Bleaching & Biocompatibility

At Kingphar, we prioritize surgical safety by utilizing advanced Oxygen Bleaching (Hydrogen Peroxide) technology. Unlike traditional chlorine bleaching, our process eliminates chemical toxicities, ensuring each laparotomy sponge is inherently biocompatible and safe for internal organ contact.

pH Balanced

Strictly maintained between 6.8 - 7.2 to match human physiological environments and minimize tissue irritation.

Zero Residue

Complete removal of natural fats, waxes, and proteins, leaving a high-purity absorbent structure for critical care.

Optical Purity

Verified under 365nm UV light to ensure zero fluorescent brighteners or optical additives.

Tensile Integrity

Oxygen treatment preserves fiber strength, preventing linting and shedding during invasive procedures.

Supply Chain Efficiency

Packaging & Logistics Data

Packaging Options

Sterile Pack (Peel-off Pouch) 1pc, 2pcs, 5pcs or 10pcs/pack
Bulk Non-Sterile 100pcs/bundle, tied with paper band
Inner Packaging Medical Grade Paper + Film / Polybag
Outer Carton 5-Layer Corrugated Export Case

Container Capacity (Est.)

Estimated based on standard 30x30cm 8-ply Laparotomy Sponges (Non-sterile).

~280 Cartons Per 20'GP Container
~680 Cartons Per 40'HQ Container
15-25 Days Lead Time for Bulk Order
FOB/CIF/DDP Global Shipping Modes
Kingphar Lab Standards

Internal Testing & Verification

01.

Absorbency Testing

Every batch of raw cotton is tested for absorbency speeds. We guarantee a sink time of < 3s, far exceeding the EN 14079 medical standard.

02.

Class 100k Cleanroom

All folding and primary packaging processes are conducted in ISO-certified Class 100,000 cleanrooms to ensure zero particulate contamination.

03.

Non-Fluorescence

Our strict bleaching process eliminates chemical brightening agents. Products are verified under UV light to be 100% fluorescence-free.

04.

Tensile & Linting

Gauze edge-finishing and weaving tension are monitored to minimize linting and maximize strength during surgical manipulation.

05.

Sterilization Integrity

For sterile SKU series, each cycle is validated with chemical indicators and biological monitors to ensure an SAL of 10⁻⁶.

06.

Chemical Purity

Testing for water-soluble substances and pH values ensures our gauze remains inert and non-irritating to sensitive surgical tissues.

Need Technical Validation?

Contact our quality team to request specific batch test results or compliance documents.

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Surgical Procedure Application
OPERATIONAL SCENARIO

Surgical Fluid Management

  • Exudate Absorption Rapidly absorbs blood and fluids during laparotomy procedures to maintain a clear surgical field.
  • Organ Protection Provides a soft, non-abrasive barrier to protect internal organs during retraction.
  • Counting Safety The integrated X-ray detectable thread and secure loop ensure easy counting and prevent retained surgical items (RSI).

Access Engineering Documentation & Product Portfolio

Operation manual - Gauze Series

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Operation Manuals & Guidelines

Access detailed technical data sheets, sterilization protocols, and professional handling guidelines for clinical staff.

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Keywords:Laparotomy Sponge

Frequently Asked Questions

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Intelligence Support

Product FAQ

What standards do Kingphar Laparotomy Sponges comply with?
Our products are fully compliant with EN 14079 standards. We maintain CE MDR, ISO 13485, and FDA registrations to meet global hospital procurement requirements.
How is the X-ray detectable thread secured?
The barium sulfate thread is either heat-sealed or woven directly into the gauze, ensuring it remains securely attached even when the sponge is fully saturated with fluids.
Are the sponges available in pre-washed versions?
Yes. Our Pre-washed series offers superior softness and immediate maximum absorbency, reducing linting compared to standard non-washed sponges.
What is the minimum order quantity (MOQ) for OEM branding?
For custom private labels, the MOQ typically starts at 50,000 packs, depending on the specific sizing and packaging complexity.
Can I choose between different cotton yarn counts?
Absolutely. We provide 21s, 32s, and 40s yarn counts with various mesh densities (13, 17, 20 threads) to balance cost and clinical performance.
What type of sterilization methods do you offer?
We provide both EO (Ethylene Oxide) and Gamma/Steam sterilization options. All sterile products come with chemical indicators for visual verification.
Is the blue loop securely attached for retraction?
Yes, the loops are cross-stitched at the corner of the sponge, designed to withstand the tension required during surgical positioning and easy counting.
How do you ensure the product is fluorescence-free?
We use a hydrogen peroxide bleaching process instead of chlorine. Each batch is inspected under 365nm UV light to ensure zero optical brighteners.

The Verdict for Procurement Officers: When evaluating medical gauze for surgical environments, the critical performance indicators are BaSO₄ purity (aim for ≥ 55%) and zero-chlorine bleaching residue. Kingphar Medical Group’s vertical production chain ensures these engineering tolerances are met consistently across all SKU series from LS-1010 to LS-4545.

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