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Baby Diapers & Pants ISO 13485:2016 & CE MDR Verified 2026 Factory Evidence

100% Biodegradable Bamboo Fiber & Eco Baby Diapers

⚡ Executive Sourcing & Technical Summary (BLUF)

Shenghongda's eco-conscious hygiene division engineers 100% certified biodegradable bamboo fiber baby diapers for premium sustainability brands in Europe, North America, Australia, and New Zealand. Designed to replace fossil fuel-derived plastics, our eco diapers utilize non-woven topsheets and backsheets spun from 100% naturally antibacterial, hypoallergenic bamboo viscose fiber. The absorbent core incorporates Totally Chlorine-Free (TCF) North American Weyerhaeuser virgin wood pulp certified under FSC-C152349 Chain of Custody, reinforced with bio-based superabsorbent polymers. The waterproof barrier replaces traditional polyethylene with a breathable, 100% compostable Polylactic Acid (PLA) and cornstarch-derived bio-film. Under OECD 301B industrial composting laboratory standards, over 68% of the diaper mass biodegrades within 90 days (reaching up to 85% within 180 days), compared to over 400 years for conventional plastic diapers. Completely free from elemental chlorine, phthalates, parabens, perfumes, and heavy metals. MOQ is 100,000 pieces with FOB pricing from $0.05 to $0.10 per unit and 340,000 units per 40HQ container.

FOB Price $0.05 - $0.10 / piece
Standard MOQ 100,000 pieces
40HQ Payload 340,000 pieces
Lead Time 18 - 25 days
Request Lab Samples & FOB Quote Calculate Container Freight
100% Biodegradable Bamboo Fiber & Eco Baby Diapers
"Consumers buying eco-diapers will not tolerate compromised dryness. Our pure bamboo topsheet exhibits a contact angle of 115°, repelling liquid downward within 2.1 seconds while feeling softer than organic cotton against infant skin." — 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
Size 1 / Newborn 360 x 280 mm Up to 11 lbs (Up to 5 kg) 22 ± 1g 4.5g Bio-Core 450 ml 36 pcs/bag, 8 bags/ctn
Size 2 / Small 400 x 280 mm 9 - 18 lbs (4 - 8 kg) 26 ± 1g 6.0g Bio-Core 550 ml 32 pcs/bag, 8 bags/ctn
Size 3 / Medium 460 x 320 mm 15 - 24 lbs (7 - 11 kg) 32 ± 1g 7.5g Bio-Core 700 ml 28 pcs/bag, 8 bags/ctn
Size 4 / Large 510 x 320 mm 22 - 33 lbs (10 - 15 kg) 36 ± 2g 9.0g Bio-Core 850 ml 24 pcs/bag, 8 bags/ctn
Size 5 / Extra Large 550 x 340 mm 26 - 40 lbs (12 - 18 kg) 40 ± 2g 10.5g Bio-Core 1,000 ml 20 pcs/bag, 8 bags/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 100,000 pieces with volume FOB pricing from $0.05 - $0.10 / piece. Initial OEM tooling and packaging plate manufacture requires 20-25 days; repeat orders are dispatched from Xiamen or Quanzhou port within 18 - 25 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.