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Disposable Underpads & Bed Pads ISO 13485:2016 & CE MDR Verified 2026 Factory Evidence

Hospital Disposable Underpads & Bed Chux (Medical Grade)

⚡ Executive Sourcing & Technical Summary (BLUF)

Shenghongda is an ISO 13485:2016 and FDA registered manufacturer of hospital-grade disposable underpads (chux) engineered for operating tables, maternity beds, nursing home furniture, and home care beds. Constructed with a 5-layer laminate architecture, our underpads feature a hydrophilic nonwoven topsheet, a tissue transfer layer, a virgin fluff pulp and Sumitomo SAP core, a secondary structural tissue layer, and a slip-resistant waterproof polyethylene (PE) backing. The surface utilizes precision diamond embossing that channels voided fluid outward in four directions, preventing pooling and accelerating strike-through below 2.0 seconds. Peripheral four-sided thermal sealing guarantees zero side border leakage even under active patient movement. Available in standard dimensions (40x60cm, 60x60cm, 60x90cm, 80x90cm) as well as heavy-duty 80x150cm and 80x180cm sizes featuring tuckable lateral nonwoven wings for hospital mattress anchoring. Grammage ranges from 40g to 130g per pad with FOB pricing of $0.04 to $0.18 per unit and container loading from 120,000 to 220,000 pieces per 40HQ.

FOB Price $0.04 - $0.18 / piece
Standard MOQ 50,000 pieces
40HQ Payload 120,000 - 220,000 pieces
Lead Time 15 - 20 days
Request Lab Samples & FOB Quote Calculate Container Freight
Hospital Disposable Underpads & Bed Chux (Medical Grade)
"For hospital purchasing tenders, tensile tear resistance is as critical as absorption. Our 5-layer thermal embossing resists up to 180 Newtons of patient repositioning shear force without core shifting or PE delamination." — 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
Chair / Basin Pad 40 x 60 cm (16" x 24") Furniture / Wheelchair 40 ± 2g 2 - 3g 600 ml 25 pcs/bag, 12 bags/ctn
Clinical Standard 60 x 60 cm (24" x 24") Examination / Cot 55 ± 3g 4 - 5g 900 ml 20 pcs/bag, 10 bags/ctn
Hospital Tender Bed Pad 60 x 90 cm (24" x 36") Full Hospital Bed 75 ± 3g 6 - 8g 1,400 ml 15 pcs/bag, 8 bags/ctn
ICU Heavy Underpad 80 x 90 cm (32" x 36") ICU / Bariatric Bed 100 ± 4g 10 - 12g 2,000 ml 10 pcs/bag, 8 bags/ctn
Tuckable Wing Sheet 80 x 180 cm (Wings 50cm ea) Mattress Wrap Wing 125 ± 5g 12 - 15g 2,400 ml 10 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 $0.04 - $0.18 / 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.