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LinksSurgical
FDA 510(k) certified surgical gloves — ASTM D3577 / D6319 compliant — manufactured in Vietnam and Thailand for US importers, distributors, and hospital supply chains.
Full product range across latex, nitrile, and polyisoprene — all surgical sizes 5.5–8.5 — with EO sterilization to SAL ≤ 10⁻⁶.
Bypass the 120% tariff with compliant Southeast Asian production, shipped direct to US West Coast ports via FOB, CIF, or DDP.
From 50-case trial orders to annual framework agreements — we match your supply chain rhythm.
Why US Buyers Choose LinksSurgical
Four critical supply chain concerns — resolved before you need to ask
Tariff-Free Supply
Production in Vietnam and Thailand — fully compliant with Section 301 tariff rules. No 120% China surcharge. Ship direct to LA / Long Beach.
FDA-Compliant
FDA 510(k) cleared (KGX), ASTM D3577 / D6319 certified. Full documentation package for US Agent filing, label review, and customs clearance.
Full Material Range
Latex, nitrile, and polyisoprene. All surgical sizes 5.5–8.5. Powder-free, EO sterilized, batch-traceable from raw material to finished case.
Low-Risk Trial
Start with 50 cases. Free samples for surgical trial. FOB, CIF, or DDP delivery. OEM packaging available. 30–45 day lead time.
How We Work with US Importers
From first inquiry to long-term partnership — a proven four-step process
Step 1: Spec Confirmation
- Tell us your requirements: Target sizes, materials (latex / nitrile / polyisoprene), packaging format, and annual volume
- We return a quote: Detailed pricing, lead times, and shipping options — within 24 hours of your inquiry
- Compliance upfront: We confirm FDA 510(k) coverage and ASTM certification for your selected product line
Step 2: Sample Validation
- Free samples shipped: We send samples matching your specifications for surgical trial and quality assessment
- Full test reports: ASTM physical test data, biocompatibility reports, and sterilization validation included with every sample set
- On-site inspection welcome: Visit our Vietnam or Thailand production facilities for factory audit and quality walk-through
Step 3: Trial Order
- Low MOQ to start: First order from 50 cases. Choose FOB (Vietnam port), CIF (US West Coast), or DDP to your US warehouse
- OEM / private label: Custom packaging with your brand — box print, label design, and barcode within 7–10 working days
- Full logistics support: We handle export customs, documentation, and US import compliance coordination
Step 4: Annual Framework
- Lock in pricing: Annual framework agreement with fixed pricing and dedicated production capacity allocation
- Supply chain visibility: Quarterly quality reviews, production forecasting reports, and batch traceability documentation
- Continuous improvement: Regular audits, compliance updates, and cost optimization recommendations based on market intelligence
Why LinksSurgical for Your US Supply Chain
We built our process around what US importers actually need — compliance, flexibility, and speed
Regulatory Readiness
FDA 510(k) · ISO 13485 · ASTM D3577/D6319
Clearance: Each product line carries FDA 510(k) clearance (Product Code: KGX). We maintain active US Agent registration.
Standards: ASTM D3577 for latex, ASTM D6319 for nitrile. Biocompatibility per ISO 10993. EO sterilization validated to SAL ≤ 10⁻⁶.
Traceability: Every batch documented — raw material COA, in-process testing, final QC release, and sterilization cycle records.
Production Capacity
Three materials · All sizes · OEM ready
Materials: Full range — latex (sensitive touch), nitrile (puncture resistance), polyisoprene (allergy-safe). Sizes 5.5–8.5 available.
OEM: Custom packaging with your brand. Box print, label design, barcode — 7–10 working day prototype turnaround.
Scalable: From 50-case trial orders to full container loads with consistent quality and batch traceability.
Turnkey Import Logistics
FOB · CIF · DDP · US warehouse options
Tariff advantage: Southeast Asian origin means zero Section 301 surcharge. We provide country-of-origin documentation for US Customs clearance.
Delivery: FOB Vietnam, CIF Los Angeles, or DDP to your US warehouse. Popular sizes pre-positioned in our US warehouse for fast replenishment.
Lead time: 30–45 days from order confirmation. Rush orders available for standard specifications.
QC & Testing
AQL 1.0/0.65 · Batch traceable · ISO 13485
In-process QC: Multi-level AQL sampling (AQL 1.0 critical, AQL 0.65 major). Every batch tested for tensile strength, elongation, and leakage.
Sterilization: EO sterilization validated per ISO 11135. Sterility assurance level (SAL) ≤ 10⁻⁶ — meets hospital-grade requirements.
Documentation: Complete batch records available — raw material COA, QC test reports, sterilization certificates, and shipping documentation.
Compliance Support
US Agent · Label review · Document package
US Agent service: We maintain active FDA registration with US Agent. You get a turnkey compliance package — no need to find your own agent.
Label compliance: Product labeling reviewed against FDA medical device labeling requirements. GUDID submission support available.
Document package: FDA 510(k) clearance letter, ASTM certificates, ISO 13485 certificate, sterilization validation, biocompatibility reports — all in one binder.
Partnership Model
Long-term · Transparent · Volume-scalable
Pricing transparency: Competitive, market-reflective pricing with no hidden fees. Annual framework lock-in available for volume customers.
Dedicated support: One account manager, one QA contact, one logistics coordinator — no runaround. We communicate in US business hours.
Growth-ready: As your glove demand grows, we scale production capacity accordingly. Quarterly business reviews with actionable supply chain data.
Ready to Secure Your Surgical Glove Supply Chain?
Tell us your target sizes, materials, and annual volume — we'll respond with a detailed quote within 24 hours
LinksSurgical is a brand of Linksshow Technology Co., Ltd. | Surgical gloves manufactured in Vietnam and Thailand.
Import duty and tariff advisory available upon request. All certifications available for download on the Certifications page.