Sterile Surgical Drapes & Fenestrated Covers
Fluid-resistant sterile surgical drapes with fenestration options — supplied as individual sheets or procedure-specific kit packs for standard and custom OR setups.
Sterile Surgical Drapes & Fenestrated Covers 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 (HS Code: 3005.90). 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 5,000 pcs (lead time: 18–26 days).
Technical details
| Material Composition | Multi-layer SMS / SMMS Non-Woven + PE Film lamination |
| Fabric Weight | 45 gsm to 65 gsm high barrier grade |
| Barrier Standard | EN 13795 High Performance & AAMI Level 4 fluid barrier |
| Fenestration Aperture | Circular, Oval, U-Shape, Incise film opening with adhesive border |
| Adhesive Border | Hypoallergenic medical grade adhesive (skin friendly) |
| Configurations | Laparotomy, Caesarean, Ophthalmic, Orthopedic, Craniotomy, Universal |
| Sterilization | Ethylene Oxide (EO) |
| Fluid Control | Integrated fluid collection pouches with suction ports (optional) |
| Shelf Life | 5 Years |
| Standard | EN 13795 / ISO 13485 / AAMI PB70 |
| Packaging | 1 pc/sterile peel pack · 20 pcs/inner carton · 5 inner cartons/master carton (100 pcs) |
| HS Code | 3005.90 |
Where it's used
- Operating Theatres & Surgical Suites
- General Surgery & Laparoscopic Interventions
- Orthopedic Joint Replacement Procedures
- Obstetric C-Section & Gynecologic Deliveries
- Cardiovascular & Neurovascular Surgeries
Official TDS, CoA & Regulatory Compliance for Sterile Surgical Drapes
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 Sterile Surgical Drapes
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 Sterile Surgical Drapes
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 Sterile Surgical Drapes
In-depth regulatory analyses, material comparisons, and international hospital procurement frameworks authored by Manshav Impex trade specialists.
Procurement FAQs for Sterile Surgical Drapes
Essential details regarding bulk ordering, sample requests, quality testing, and global export shipping.
What is the HS code for Sterile Surgical Drapes & Fenestrated Covers exported from India?
Sterile Surgical Drapes & Fenestrated Covers is exported under HS heading 3005.90. 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 Sterile Surgical Drapes & Fenestrated Covers?
Material Composition: Multi-layer SMS / SMMS Non-Woven + PE Film lamination; Fabric Weight: 45 gsm to 65 gsm high barrier grade; Barrier Standard: EN 13795 High Performance & AAMI Level 4 fluid barrier; Fenestration Aperture: Circular, Oval, U-Shape, Incise film opening with adhesive border; Adhesive Border: Hypoallergenic medical grade adhesive (skin friendly). Export packing: 1 pc/sterile peel pack · 20 pcs/inner carton · 5 inner cartons/master carton (100 pcs). Full technical data sheets are shared with every quotation.
What is the Minimum Order Quantity (MOQ) and lead time for Sterile Surgical Drapes & Fenestrated Covers?
The standard MOQ for Sterile Surgical Drapes & Fenestrated Covers is 5,000 pcs with an estimated production and export dispatch lead time of 18–26 days. We also accommodate trial shipments and mixed-container orders for hospital networks and distributors.
Which quality certificates and test reports accompany Sterile Surgical Drapes & Fenestrated Covers?
Sterile Surgical Drapes & Fenestrated Covers is produced at a vetted, ISO 13485-certified partner factory in India and made to CE MDR, ISO 13485, EN 13795, AAMI PB70 (HS Code 3005.90). 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 Sterile Surgical Drapes & Fenestrated Covers 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 Sterile Surgical Drapes & Fenestrated Covers?
Yes, we arrange complete OEM and private-label programs for Sterile Surgical Drapes & Fenestrated Covers through our partner factories, including custom artwork, barcode labeling, language-specific inner boxes, and bulk export packaging (1 pc/sterile peel pack · 20 pcs/inner carton · 5 inner cartons/master carton (100 pcs)).
What export shipping and payment terms are available for Sterile Surgical Drapes & Fenestrated Covers?
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 Sterile Surgical Drapes
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.
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