Non-Sterile Blue Sponge Counter Bags

The Non-Sterile Blue Sponge Counter Bags are essential perioperative safety tools designed for the systematic collection and visual verification of used surgical sponges. By providing a structured way to count sponges outside the sterile field, these bags are a critical component in preventing Retained Surgical Items (RSI) and ensuring patient safety during surgical procedures.

With over 25 years of packaging manufacturing expertise and a dedicated medical packaging division, Huayue Group supplies these products to hospitals, surgical centres, and GPOs across more than 50 countries. Custom configurations — including pocket count, bag dimensions, and private-label printing — are available to meet the specific procedural protocols of your institution.

Technical Specifications & Compliance

Huayue products are manufactured under a rigorous quality framework, distinguishing them from generic commodity packaging through medical-grade certification.

Key Features & Clinical Benefits

• High-Integrity Pockets - Clear pocket construction allows for immediate visual confirmation of sponge type and quantity.
  
  
• Leak-Proof Seal - Precision-engineered seals prevent fluid leakage, ensuring a clean and hazardous-free OR environment (Inspected to AQL 1.0).
  
  
• Non-Toxic Colorant - The blue tint is formulated to be non-interfering with clinical imaging and fluid measurement.
  
  
• Full Traceability - Each batch carries a unique lot number for complete tracking from raw material to the final clinical user.
  
  

Manufacturing Excellence

Production occurs in high-standard controlled environments to ensure medical-grade purity

• Cleanroom Production - Manufactured in ISO Class 7 or Class 8 cleanrooms.
  
  
• Environmental Control - HEPA-filtered positive-pressure air systems with continuous particle monitoring (≥0.5 µm).
  
  
• Strict Protocols - Full gowning, personnel training logs, and validated temperature/humidity controls (18–22°C, 30–60% RH).
  
  
• Validation - All facilities are backed by complete IQ/OQ/PQ 
  
  
• Production Capacity & Lead Time - Huayue Group operates four production bases in China and Cambodia with a combined annual output approaching 1 billion RMB. This scale supports high-volume blanket orders, buffer stock programs, and flexible MOQs, with standard lead times of 30–45 days and expedited options available for urgent procurement needs.

Quality Control Standards (AQL)

Huayue adhere to ISO 2859-1 (ANSI/ASQ Z1.4) standards to ensure consistent batch quality

• Critical Defects (AQL 1.0) - Zero tolerance for seal leakage or transparency issues.
  
  
• Major Defects (AQL 2.5) - Strict control over dimensional accuracy and pocket counts.
  
  
• Minor Defects (AQL 4.0) - Management of cosmetic surface marks and label alignment.
  
  
• In-Process & Outgoing Inspection - Every production run undergoes both in-process checks at key manufacturing stages and a final outgoing inspection prior to shipment. Inspection records are retained and made available as part of the lot release documentation.
  
  

Documentation Package for Procurement

For GPOs and institutional buyers, huayue provide a comprehensive "Desk Audit" package

• FDA Establishment Registration & CE Declaration of Conformity.
  
  
• Full ISO 10993 Biocompatibility Reports(not just certificates).
  
  
• Material Safety Data Sheets (MSDS/SDS).
  
  
• Certificate of Conformance (CoC) provided with every lot.
  
  
• Multilingual Documentation & Global Support - All compliance documents are available in English and Chinese, with additional language support upon request. Dedicated account managers based in our New York and Hong Kong service centres provide localised procurement assistance, regulatory Q&A, and post-shipment support for customers across North America, Europe, Asia-Pacific, and beyond.