FDA Registered Diaper OEM Factory for North America
BLUF (Bottom Line Up Front): For North America (USA & Canada) procurement directors and brand owners, Quanzhou Shenghongda Hygiene Products Co., Ltd. provides direct manufacturing engineered to resolve regional compliance mandates and climate performance requirements. US market compliant diaper manufacturing: FDA Class I, Prop 65 tested, TCF pulp, hypoallergenic. Supporting high-absorbency L/XL/XXL sizes for private labels.
Regional Compliance, Audits & Customs Clearances
Pre-cleared regulatory documentation preventing customs detention and retail compliance rejection across North America (USA & Canada).
U.S. FDA Class I Listing
Foreign facility registration & medical device listing under HTS 9619.00.
California Prop 65 & CPSIA
Lead-free, phthalate-free, non-toxic heavy metal laboratory screening.
Toxicological Risk Assessment (TRA)
Third-party hypoallergenic bio-compatibility certification.
Material Engineering & Sizing Tailored for North America (USA & Canada)
Physically optimized core blends, topsheet textures, and fit contours matched to regional consumer anatomy and climate conditions.
Container Load Optimization & Direct Port Shipping
Mathematical container utilization maximizing 40HQ high-cube payload to significantly minimize per-unit ocean landed cost.
Direct Ocean Logistics & Container Loading Model from Xiamen Port
Matte premium stand-up zip pouches or compressed retail polybags with Amazon FBA carton barcodes.
Technical Data Sheet (TDS) · M, L, XL, XXL Specifications
Physical parameters measured under ISO 11948-1 Rothwell method, ASTM E96, and ISO 20743 standards.
| Engineering Parameter (工程规格参数) | Size M (Medium) | Size L (Large) | Size XL (Extra Large) | Size XXL (Double Large) | Testing Standard & Citation (出处依据) |
|---|---|---|---|---|---|
| Baby Weight (适用婴儿体重) | 6 – 11 kg13.2 – 24.3 lbs | 9 – 14 kg19.8 – 30.9 lbs | 12 – 17 kg26.5 – 37.5 lbs | ≥ 15 kg≥ 33.1 lbs | Ergonomic Anthropometric Standards |
| Dimensions L × W (展开物理尺寸) | 450 mm × 320 mm17.7" × 12.6" | 490 mm × 320 mm19.3" × 12.6" | 530 mm × 320 mm20.9" × 12.6" | 550 mm × 340 mm21.7" × 13.4" | Caliper Exact Measurement (±5mm) |
| Item Net Weight (单片成品净克重) | 28.0 g ± 1.5 g0.99 oz ± 0.05 oz | 32.0 g ± 1.5 g1.13 oz ± 0.05 oz | 36.0 g ± 1.5 g1.27 oz ± 0.05 oz | 40.0 g ± 1.5 g1.41 oz ± 0.05 oz | Precision Electronic Balance |
| Sumitomo SAP Weight (日本住友高分子SAP) | 8.0 g (28.5%) | 10.0 g (31.2%) | 11.5 g (31.9%) | 13.0 g (32.5%) | Automated Loss-in-Weight Feeder |
| TCF Virgin Fluff Pulp (进口无氯漂白纯木浆) | 10.0 g (Imported TCF) | 11.5 g (Imported TCF) | 13.0 g (Imported TCF) | 14.5 g (Imported TCF) | FSC®-C152775 Chain-of-Custody Pulp |
| Saturated Absorption (饱和吸水容量) | ≥ 800 ml≥ 27.1 fl oz | ≥ 1000 ml | ≥ 1100 ml | ≥ 1200 ml | Saline Immersion Gravimetric Method |
| 0.5 psi Pressurized Rewet (加压回渗量) | ≤ 0.20 g | ≤ 0.25 g | ≤ 0.25 g | ≤ 0.30 g | YS255 Precision Rewet Tester |
| 100ml Strike-Through Time (首轮下渗时间) | < 3.5 sec | < 3.5 sec | < 4.0 sec | < 4.0 sec | YS-38 Liquid Penetration Analyzer |
| Backsheet MVTR (透气底膜透湿率) | ≥ 2600 g/m²·24h | ≥ 2600 g/m²·24h | ≥ 2800 g/m²·24h | ≥ 2800 g/m²·24h | ASTM E96 Cup Permeation Method |
| Inner Pack Count (内层包装形式) | 44 pcs / Dual Polybag | 40 pcs / Dual Polybag | 36 pcs / Dual Polybag | 32 pcs / Dual Polybag | Photoelectric Automated Counting |
| Outer Carton Pack (外层装箱规格) | 4 Bags / Master Carton | 4 Bags / Master Carton | 4 Bags / Master Carton | 4 Bags / Master Carton | 5-Ply High-Compression Corrugated Box |
| 40HQ Container Max Load (高柜装载极限) | 420,000 pcs | 390,000 pcs | 360,000 pcs | 330,000 pcs | Hydraulic Bale Baling & Math Model |
Start Your North America (USA & Canada) OEM/ODM Production Run
Direct export desk: export@shenghongdadiapers.com. Free physical sample kits shipped globally within 72 hours with full lab test reports and pre-filled customs declarations.