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

Baby Pull-Up Training Pants (Step-In Baby Pants)

⚡ Executive Sourcing & Technical Summary (BLUF)

Shenghongda manufactures high-speed converted baby pull-up training pants engineered for toddlers in active developmental stages and potty-training transitions. Built with an ultrasonic-bonded 360-degree soft bubble waistband containing over 40 individual lycra strands, our training pants provide continuous tension without marking sensitive abdominal skin. The ultra-thin Japanese Sumitomo SAP core absorbs moisture within 2.3 seconds, holding up to 800-1,100 ml while maintaining a flat, unbulked profile between the toddler's legs. After voiding, parents can easily tear the ultrasonic side seams for clean removal, roll the pant into a compact bundle, and secure it with the integrated adhesive disposal tape on the backsheet. Available with hot-air nonwoven embossed liners, plant-based chamomile or aloe skin protectants, and customized cartoon backsheet graphics. Sizes include M, L, XL, XXL, and XXXL with an MOQ of 50,000 to 160,000 units, FOB $0.04 to $0.07, loading 350,000 pieces per 40HQ container.

FOB Price $0.04 - $0.07 / piece
Standard MOQ 50,000 - 160,000 pieces
40HQ Payload 350,000 pieces
Lead Time 15 - 20 days
Request Lab Samples & FOB Quote Calculate Container Freight
Baby Pull-Up Training Pants (Step-In Baby Pants)
"The greatest challenge in baby pants is waist tension uniformity. By utilizing multi-strand elastic insertion under servo tension feedback, our waistbands exert a constant 3.2 N force across all expansion angles, eliminating pinch marks during active toddler play." — Lana, Senior Global Export Lead.
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
Medium (M) 460 x 400 mm 13 - 24 lbs (6 - 11 kg) 30 ± 1g 7 - 8g 650 ml 30 pcs/bag, 8 bags/ctn
Large (L) 490 x 410 mm 20 - 31 lbs (9 - 14 kg) 34 ± 1g 8 - 9g 800 ml 26 pcs/bag, 8 bags/ctn
Extra Large (XL) 520 x 420 mm 26 - 37 lbs (12 - 17 kg) 38 ± 2g 9 - 10g 950 ml 22 pcs/bag, 8 bags/ctn
XXL Training 550 x 430 mm Over 33 lbs (15+ kg) 42 ± 2g 10 - 12g 1,100 ml 18 pcs/bag, 8 bags/ctn
XXXL Junior 580 x 440 mm Over 40 lbs (18+ kg) 46 ± 2g 12 - 14g 1,250 ml 16 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 - $0.07 / 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.