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

OEM Baby Tape Diapers (Open Style Magic Tape Diapers)

⚡ Executive Sourcing & Technical Summary (BLUF)

Shenghongda's OEM baby tape diapers represent over 20 years of precision converting engineering, formulated for international private labels and regional supermarket brands. Built with an advanced ultra-thin composite absorbent core (sub-2.0mm thickness), our diapers replace bulky fluff padding with high-concentration Japanese Sumitomo Superabsorbent Polymer (SAP, CRC >= 32 g/g) bound by dual thermal-bonded nonwoven webs. This core delivers instant acquisition in under 2.5 seconds and resists clumping, sagging, or rupture during infant crawling. A silky hot-air through embossed nonwoven topsheet provides a soft, cloud-like touch against newborn skin, and dual 3D hydrophobic standing leg barriers offer 35mm of vertical leak containment. Features include refastenable S-cut magic velcro side tapes, a wide elasticized back waistband, an air-permeable clothlike backsheet with MVTR > 2,800 g/m²/24h, and a 3-stripe color wetness indicator. Sizes range from Newborn (NB) to XXL (28-45+ lbs) at an MOQ of 50,000 to 160,000 pieces per size, FOB $0.04 to $0.08, with 380,000 units per 40HQ container.

FOB Price $0.04 - $0.08 / piece
Standard MOQ 50,000 - 160,000 pieces
40HQ Payload 380,000 pieces
Lead Time 15 - 20 days
Request Lab Samples & FOB Quote Calculate Container Freight
OEM Baby Tape Diapers (Open Style Magic Tape Diapers)
"Baby skin is 30% thinner than adult skin, making diaper rash prevention a matter of rewet physics. Under third-party SGS testing, our composite SAP core records a rewet of just 0.04g after 3x60ml urine insults." — 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
Newborn (NB) 360 x 280 mm Up to 10 lbs (Up to 4.5 kg) 20 ± 1g 4 - 5g 400 ml 40 pcs/bag, 8 bags/ctn
Small (S) 390 x 280 mm 8 - 14 lbs (4 - 8 kg) 24 ± 1g 5 - 6g 500 ml 36 pcs/bag, 8 bags/ctn
Medium (M) 450 x 320 mm 13 - 24 lbs (6 - 11 kg) 29 ± 1g 7 - 8g 650 ml 32 pcs/bag, 8 bags/ctn
Large (L) 500 x 320 mm 20 - 31 lbs (9 - 14 kg) 33 ± 1g 8 - 9g 800 ml 28 pcs/bag, 8 bags/ctn
Extra Large (XL) 540 x 340 mm Over 26 lbs (12 - 17 kg) 37 ± 2g 9 - 10g 950 ml 24 pcs/bag, 8 bags/ctn
XXL / Junior 570 x 350 mm Over 33 lbs (15+ kg) 40 ± 2g 10 - 11g 1,100 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 50,000 - 160,000 pieces with volume FOB pricing from $0.04 - $0.08 / piece. 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.