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Wet Wipes & Cleansing Tissues ISO 13485:2016 & CE MDR Verified 2026 Factory Evidence

EDI Pure Water Wet Wipes & Cleansing Tissues (OEM/ODM)

⚡ Executive Sourcing & Technical Summary (BLUF)

Shenghongda produces pharmaceutical-grade wet wipes and personal cleansing tissues formulated with 99% pure water treated through an automated 7-stage Electrodeionization (EDI) purification system. Free from alcohol, parabens, artificial fragrances, fluorescent brighteners, and harsh chemical surfactants, our wipe formula complies with the most stringent cosmetic safety standards including EU Regulation (EC) No 1223/2009 and US FDA cosmetics guidelines. The fabric substrate utilizes high-density pearl-embossed cross-lapped spunlace nonwoven (45 to 60 gsm) made from premium viscose and polyester blends, offering zero linting, exceptional wet strength, and a plush tactile feel. For environmentally focused brands, we offer 100% plant-based biodegradable and flushable viscose/wood pulp spunlace substrates that disperse in wastewater systems under INDA/EDANA GD4 standards. Packaging configurations include pocket packs (10ct, 20ct) and family-sized dispensing packs (80ct, 100ct) with moisture-lock aluminum inner lining and resealable flip-top snap lids. MOQ is 300,000 units/packs with FOB pricing from $0.20 to $0.65 per pack.

FOB Price $0.20 - $0.65 / pack
Standard MOQ 300,000 packs / pieces
40HQ Payload 110,000 - 150,000 packs (80ct flip-lid)
Lead Time 15 - 20 days
Request Lab Samples & FOB Quote Calculate Container Freight
EDI Pure Water Wet Wipes & Cleansing Tissues (OEM/ODM)
"Water purity is the soul of a wet wipe. Our 7-stage EDI process reduces electrical conductivity to under 0.1 µS/cm and microbial limits to < 1 CFU/ml, ensuring our preservative system requires less than half the active agents of standard wipes." — Ivana Huang, Chief Technical Director.
Standard Product Matrix & Lab Benchmarks

Comprehensive Engineering Sizing & Sourcing Parameters

Tested in accordance with ISO 11948-1 (Rothwell method), ISO 13485:2016 quality management standards, and European MDR 2017/745 regulatory guidelines.

Size / Tier Dimensions Target Waist / Application Total Weight SAP Grammage ISO 11948-1 Capacity Packaging Specification
Mini Pocket Pack 140 x 150 mm sheet Travel / Pocket (10ct) 45 gsm pearl N/A 3.5x Wet Ratio 10 pcs/pack, 120 packs/ctn
Standard Travel Pack 150 x 200 mm sheet On-the-Go (20ct) 50 gsm pearl N/A 3.8x Wet Ratio 20 pcs/pack, 60 packs/ctn
Family Flip-Lid Pack 150 x 200 mm sheet Nursery / Home (80ct) 50 gsm embossed N/A 3.8x Wet Ratio 80 pcs/pack, 24 packs/ctn
Heavy Adult Incontinence Wipe 200 x 250 mm sheet Hospital Bedside (60ct) 60 gsm thick N/A 4.2x Wet Ratio 60 pcs/pack, 20 packs/ctn
Flushable Eco Wipe 140 x 200 mm sheet Toilet Flushable (42ct) 55 gsm woodpulp N/A 3.6x Wet Ratio 42 pcs/pack, 36 packs/ctn

🔬 Laboratory Testing Standards & Protocols

  • ISO 11948-1 (Rothwell Method): Whole-product immersion testing verifying absolute fluid retention.
  • Rewet Rate (SGS / CNAS Protocol): Sub-0.10g surface moisture residue under 5 kPa physiological pressure.
  • Strike-Through Velocity: Complete acquisition of 100ml synthetic urine in < 2.5 seconds.
  • Centrifuge Retention Capacity (CRC): SAP polymer rating ≥ 32 g/g under 0.9% saline centrifuge.
  • Moisture Vapor Transmission Rate (MVTR): Breathable backsheet > 2,500 g/m²/24h.

🌐 Supply Chain Tier-1 Materials

  • Superabsorbent Polymer: Japanese Sumitomo Chemical (high gel-blocking resistance).
  • Fluff Pulp: Weyerhaeuser Southern Bleached Softwood Kraft (SBSK, FSC certified).
  • Hot-Melt Adhesives: Henkel Optal & Bostik medical-grade hypoallergenic bonding.
  • Elastic & Fasteners: Hyosung Creora lycra strands and 3M hook-and-loop magic tapes.
  • Cleanroom Environment: Class 100,000 GMP HEPA-filtered with optical vision defect cameras.
Direct Factory Export Desk

Request Sample Kit & Official FOB Quotation

Shipped via international DHL / FedEx courier within 72 hours. All custom SAP formulations, sizing, and packaging welcomed.

Frequently Asked Questions by Global Buyers

What is the minimum order quantity (MOQ) and production turnaround?

Our standard private label MOQ is 300,000 packs / pieces with volume FOB pricing from $0.20 - $0.65 / pack. Initial OEM tooling and packaging plate manufacture requires 20-25 days; repeat orders are dispatched from Xiamen or Quanzhou port within 15 - 20 days.

Can we request custom SAP concentrations, dimensions, and private label polybags?

Yes. As a 20-year OEM/ODM manufacturer, all product parameters—including SAP origin, fluff core GSM, backsheet film color/thickness, wetness indicators, and packaging count—are fully customizable to your retail or clinical tender specifications.

How do you verify medical device and international trade compliance?

Shenghongda operates under strict ISO 13485:2016 medical device standards, CE MDR (EU 2017/745), US FDA Class I establishment registration, FSC-C152349 chain of custody, and amfori BSCI social audit certifications. Inspection reports and TDS documents are provided with every batch.