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

Anatomical Incontinence Pads & Insert Booster Pads

⚡ Executive Sourcing & Technical Summary (BLUF)

Shenghongda's anatomical incontinence pads feature an ergonomic figure-8 contour specifically developed for clinical institutional use, ambulatory daytime incontinence, and as high-capacity booster inserts inside primary adult briefs. The specialized contour aligns precisely with male and female groin anatomy, minimizing bulkiness between the thighs while concentrating maximum absorbent volume directly beneath the voiding zone. Each pad incorporates a high-density Sumitomo SAP and airlaid fluff core providing 800 ml to 1,800 ml of fluid retention under ISO 11948-1 testing. Two longitudinal side elastics create a 3D cupping effect that channels liquid into the core before lateral spread can occur. The bottom layer features an optional wide adhesive tracking strip and breathable clothlike backing to secure the insert inside fixation mesh pants or standard underwear without slippage. MOQ is 50,000 pieces with FOB pricing from $0.03 to $0.05 per unit, allowing high container payloads of 180,000 pieces per 40HQ.

FOB Price $0.03 - $0.05 / piece
Standard MOQ 50,000 pieces
40HQ Payload 180,000 pieces
Lead Time 15 - 20 days
Request Lab Samples & FOB Quote Calculate Container Freight
Anatomical Incontinence Pads & Insert Booster Pads
"In European hospital tenders, anatomical pads combined with stretch fixation pants reduce per-patient daily expenditure by up to 38% compared to full briefs for ambulatory individuals, while delivering equal leakage protection." — 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
Normal (Plus) 480 x 250 mm Universal Insert 35 ± 2g 4 - 5g 800 ml 30 pcs/bag, 8 bags/ctn
Super (Extra) 580 x 290 mm Universal Insert 45 ± 2g 6 - 8g 1,200 ml 30 pcs/bag, 6 bags/ctn
Maxi (Institutional) 640 x 330 mm Universal Insert 60 ± 3g 10 - 12g 1,800 ml 20 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 with volume FOB pricing from $0.03 - $0.05 / 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.