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Adult Incontinence & Healthcare ISO 13485:2016 & CE MDR Verified 2026 Factory Evidence

OEM Adult Taped Diapers & Heavy Incontinence Briefs

⚡ Executive Sourcing & Technical Summary (BLUF)

Shenghongda Hygiene Products Co., Ltd. (Est. 2004) manufactures institutional and medical-grade adult taped diapers designed for severe incontinence, post-operative recovery, and bedridden patient nursing. Utilizing 16 full-servo high-speed converting lines in an 8,000 m² Class 100,000 GMP cleanroom, our briefs feature a dual-core architecture combining Japanese Sumitomo Superabsorbent Polymer (SAP, CRC >= 32 g/g) and North American Weyerhaeuser FSC-certified virgin fluff pulp. Tested under the ISO 11948-1 Rothwell method, total absorption capacity spans 1,800 ml to 3,500 ml for standard healthcare tenders, with heavy-night institutional models absorbing up to 6,000 ml. Rewet remains strictly below 0.1g (sub-0.05g on dry-core configurations), strike-through time is under 2.5 seconds, and breathable backsheet MVTR exceeds 2,500 g/m²/24h. Standard private-label MOQ is 50,000 units with FOB pricing ranging from $0.09 to $0.23 per piece, delivering 85,000 pieces per 40HQ container.

FOB Price $0.09 - $0.23 / piece
Standard MOQ 50,000 pieces (1x20GP trial)
40HQ Payload 85,000 pieces (compressed polybags)
Lead Time 15 - 20 days
Request Lab Samples & FOB Quote Calculate Container Freight
OEM Adult Taped Diapers & Heavy Incontinence Briefs
"In medical-grade adult diaper converting, our primary focus is skin microclimate regulation. By combining Sumitomo SAP with Weyerhaeuser SBSK pulp in a 65:35 ratio, we achieve sub-0.05g rewet values under 5 kPa pressure, preventing pressure injuries and maceration in long-term hospital patients." — Ivana Huang, Chief Technical Director at Shenghongda Hygiene.
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) 800 x 650 mm 28" - 44" (71 - 112 cm) 95 ± 3g 10 - 14g 2,200 ml 10 pcs/bag, 10 bags/ctn
Large (L) 900 x 750 mm 40" - 56" (102 - 142 cm) 105 ± 3g 12 - 16g 2,800 ml 10 pcs/bag, 10 bags/ctn
Extra Large (XL) 1000 x 800 mm 52" - 66" (132 - 168 cm) 115 ± 4g 14 - 18g 3,400 ml 10 pcs/bag, 8 bags/ctn
Bariatric (XXL/3XL) 1100 x 900 mm 62" - 78" (157 - 198 cm) 135 ± 5g 20 - 25g 5,000 - 6,000 ml 8 pcs/bag, 6 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 pieces (1x20GP trial) with volume FOB pricing from $0.09 - $0.23 / 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.