Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4)
Sterile, fluid-resistant SMS/SMMS non-woven surgical gown with knit cuffs and reinforced critical zones for full operating room barrier protection.
Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4) is exported by Manshav Impex, an Indian manufacturer & exporter, and produced at vetted, ISO 13485-certified partner factories to CE MDR, ISO 13485, EN 13795, AAMI PB70 Level 3/4 (HS Code: 6210.10). Available for global export with FOB/CIF wholesale pricing, private label OEM packaging, certificates and test reports shared with every quotation, and standard MOQ of 10,000 pcs (lead time: 15–22 days).
Technical details
| Material | Medical Grade SMMS / SMMMS Polypropylene Non-Woven |
| Barrier Rating | AAMI PB70 Level 3 (Standard) & Level 4 (Impervious Reinforced) |
| Grammage | 45 gsm (body) / 60 gsm (poly-reinforced chest & sleeves) |
| Cuff Design | Soft knitted polyester cuffs (100% latex-free) |
| Closure | Double back-tie + Velcro neck collar fastening |
| Seam Construction | Ultrasonic welded liquid-proof hermetic seams |
| Sizes Available | S, M, L, XL, XXL, XXXL |
| Sterilization | Ethylene Oxide (EO) |
| Standard | EN 13795 / AAMI PB70 / ISO 13485 |
| Packaging | 1 pc/sterile pack with 2 hand towels · 50 pcs/master export carton |
| HS Code | 6210.10 |
Where it's used
- Operating Theatres & Sterile Surgical Suites
- Orthopedic & Joint Replacement Surgery
- Cardiac, Vascular & Organ Transplant Procedures
- Emergency Trauma & Burn Surgery Units
- Military Field Operating Facilities
Official TDS, CoA & Regulatory Compliance for Disposable SMS Non-Woven Surgeon's Gown
Manshav Impex maintains complete technical files and batch-level quality documentation for institutional hospital tenders, Ministry of Health (MOH) product registrations, and customs clearance.
The partner factory's audited Quality Management System covers Class 100,000 cleanroom production and packaging.
Complies with European Medical Device Regulation (EU) 2017/745 with complete Technical Construction File.
Lot-specific chemical, physical, and sterility validation certificates issued with every dispatched consignment.
Customized Common Technical Document dossiers for NAFDAC, SFDA, PPB, INVIMA, EDA, and SAHPRA registrations.
International Delivery & Regulatory Compliance for Disposable SMS Non-Woven Surgeon's Gown
Export consignments dispatched from Port Mundra & Port Nhava Sheva (JNPT), India with full batch documentation (CoA, COO, Sterilization Validation) and the documents your local registration requires.
Container Capacity & MOQ Planner for Disposable SMS Non-Woven Surgeon's Gown
Estimate shipping volumes, gross weight, and container stuffing capacity for ocean freight consignments from Port Mundra & Nhava Sheva.
| Destination Region | Key Gateway Entry Ports | Sea Transit | Air Cargo | Target Regulatory Dossier |
|---|---|---|---|---|
| East Africa | Mombasa (Kenya), Dar es Salaam (Tanzania), Port of Djibouti (Ethiopia corridor) | 10–14 Days | 2–4 Days | PPB Kenya, TMDA Tanzania, EFDA Ethiopia, NDA Uganda, FDA Rwanda |
| West Africa | Lagos / Apapa & Tin Can (Nigeria), Tema & Takoradi (Ghana), Abidjan (Côte d'Ivoire), Dakar (Senegal) | 22–30 Days | 3–5 Days | NAFDAC CRIA (Nigeria), FDA G-FIRMS (Ghana), AIRP (Côte d'Ivoire), ARP (Senegal) |
| Southern Africa | Durban & Cape Town (South Africa), Walvis Bay (Namibia), Beira & Maputo (Mozambique) | 16–22 Days | 3–5 Days | SAHPRA Section 21 / MDEL (South Africa), MCAZ (Zimbabwe), ZAMRA (Zambia) |
| North Africa | Alexandria & Port Said (Egypt), Casablanca & Tanger Med (Morocco), Algiers (Algeria), Port Sudan | 12–20 Days | 2–4 Days | EDA MeDevice (Egypt), DPML (Algeria), Ministry of Health (Morocco), NMPB (Sudan) |
| Latin America & Caribbean | Santos & Paranaguá (Brazil), Manzanillo & Veracruz (Mexico), Buenaventura & Cartagena (Colombia), Callao (Peru), Guayaquil (Ecuador), Valparaíso & San Antonio (Chile), Port of Spain (Trinidad), Kingston (Jamaica) | 24–36 Days | 4–6 Days | ANVISA RDC 751 (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), DIGEMID (Peru), ARCSA (Ecuador), ISP (Chile), CARPHA (Caribbean) |
| Middle East & GCC | Jebel Ali & Khalifa Port (UAE), Dammam & Jeddah (Saudi Arabia), Shuwaikh (Kuwait), Muscat (Oman), Hamad (Qatar), Umm Qasr (Iraq) | 4–8 Days | 1–3 Days | SFDA (Saudi Arabia), MoHAP (UAE), MOPH (Qatar), MoH (Kuwait/Oman), KIMADIA (Iraq) |
| Southeast Asia & Oceania | Manila & Cebu (Philippines), Cat Lai & Haiphong (Vietnam), Port Klang (Malaysia), Tanjung Priok (Indonesia), Laem Chabang & Bangkok (Thailand), Melbourne & Sydney (Australia) | 12–24 Days | 2–5 Days | TGA ARTG (Australia), CDRRHR AMDD (Philippines), MoH Decree 98 (Vietnam), MDA (Malaysia), BPOM (Indonesia), Thai FDA (Thailand) |
| Central & South Asia | Chittagong (Bangladesh), Colombo (Sri Lanka), Tashkent Rail/Air (Uzbekistan), Almaty (Kazakhstan) | 5–18 Days | 2–4 Days | DGDA (Bangladesh), NMRA (Sri Lanka), Pharmagency (Uzbekistan), NDDA (Kazakhstan) |
| Europe & UK | Port of Felixstowe, Southampton & London Gateway (UK), Port of Dublin (Ireland), Port of Hamburg & Rotterdam (EU) | 18–26 Days | 2–4 Days | MHRA UKCA & NHS Supply Chain (UK), HPRA & HSE (Ireland), EU MDR 2017/745, CE Mark & BfArM (Germany/EU) |
| North America | Port of New York/New Jersey, Port of Houston, Port of Long Beach/Los Angeles (USA) | 24–32 Days | 3–5 Days | US FDA 510(k), Establishment Registration & Device Listing (USA) |
Clinical Standards & Sourcing Insights for Disposable SMS Non-Woven Surgeon's Gown
In-depth regulatory analyses, material comparisons, and international hospital procurement frameworks authored by Manshav Impex trade specialists.
Procurement FAQs for Disposable SMS Non-Woven Surgeon's Gown
Essential details regarding bulk ordering, sample requests, quality testing, and global export shipping.
What is the HS code for Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4) exported from India?
Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4) is exported under HS heading 6210.10. The full 8-digit Indian tariff line is confirmed on the commercial invoice and shipping bill for each order, as your customs broker needs it for import duty and registration.
What are the specifications and export packing of Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4)?
Material: Medical Grade SMMS / SMMMS Polypropylene Non-Woven; Barrier Rating: AAMI PB70 Level 3 (Standard) & Level 4 (Impervious Reinforced); Grammage: 45 gsm (body) / 60 gsm (poly-reinforced chest & sleeves); Cuff Design: Soft knitted polyester cuffs (100% latex-free); Closure: Double back-tie + Velcro neck collar fastening. Export packing: 1 pc/sterile pack with 2 hand towels · 50 pcs/master export carton. Full technical data sheets are shared with every quotation.
What is the Minimum Order Quantity (MOQ) and lead time for Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4)?
The standard MOQ for Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4) is 10,000 pcs with an estimated production and export dispatch lead time of 15–22 days. We also accommodate trial shipments and mixed-container orders for hospital networks and distributors.
Which quality certificates and test reports accompany Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4)?
Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4) is produced at a vetted, ISO 13485-certified partner factory in India and made to CE MDR, ISO 13485, EN 13795, AAMI PB70 Level 3/4 (HS Code 6210.10). The manufacturing partner's certificates, batch test reports (CoA, sterility), EO/Gamma sterilization records and Certificate of Origin (COO) are shared with every quotation, with the certificate holder named.
Are product samples available for evaluation prior to bulk ordering?
Yes, we provide physical samples of Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4) for clinical evaluation, hospital tenders, and distributor approval. Sample courier costs are adjusted against your first commercial bulk order.
Do you offer OEM private-label branding and custom packaging for Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4)?
Yes, we arrange complete OEM and private-label programs for Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4) through our partner factories, including custom artwork, barcode labeling, language-specific inner boxes, and bulk export packaging (1 pc/sterile pack with 2 hand towels · 50 pcs/master export carton).
What export shipping and payment terms are available for Disposable SMS Non-Woven Surgeon's Gown (AAMI Level 3/4)?
We support FOB, CIF, CFR, DDP, and EXW Incoterms via sea, air, and express courier freight. Payment terms include advance T/T and Irrevocable Letter of Credit (L/C at sight).
Request Wholesale Pricing for Disposable SMS Non-Woven Surgeon's Gown
Share your quantity and destination and our export team will send a detailed quotation within one business day.
Full documentation
Invoice, packing list, COO and certificates included.
Global shipping
Sea, air and courier freight to your port.
Related products
Sterile Latex Surgical Gloves (Powdered & Powder-Free)
Pre-donned sterile natural latex surgical gloves with curved anatomical fingers, micro-textured anti-slip finish, beaded cuff, available in powdered and powder-free polymer coated grades.
Sterile Surgical Blades & Scalpel Handles
Ultra-sharp sterile surgical blades crafted from premium surgical steel with precision-ground edges and matching ergonomic scalpel handles for OR use.
Disposable Sterile Scalpels with Ergonomic Handle (#10 to #24)
Pre-assembled sterile single-use disposable scalpels combining high-precision stainless or carbon steel blades firmly integrated into graduated ergonomic ABS plastic handles with blade guards.