The theatre coordinator at a 280-bed private hospital in Accra pulled up their drape invoice from the Ghana distributor — AAMI Level 3 fenestrated packs, a 12-month contract, locked in at a price that made the CFO wince every quarter. The distributor had always said: "That's what compliant surgical drapes cost." Nobody had bothered to check whether that was true until a KEMSA tender comparison sheet landed in her inbox showing Indian FOB prices 60 percent lower for the same EN 13795 Standard Performance rating.
Manshav Impex exports ISO 13485–certified, EN 13795–compliant disposable surgical drapes from India — AAMI Level 2, 3, and 4 variants, C-section and orthopaedic procedure packs, and custom OEM sets — FOB Nhava Sheva, MOQ 500 packs, 21-day lead time.
As a surgical drapes exporter from India, Manshav Impex manufactures SMS and SMMS disposable surgical drapes, procedure packs, and custom theatre sets under ISO 13485, CE, and WHO-GMP compliant manufacturing practices — and we supply them directly to hospitals, distributors, and procurement agencies in over 40 countries. This guide covers exactly what institutional buyers need to know before their next drape tender.
Surgical Drapes · Full Catalogue · Get a Quote · WhatsApp +91 84601 91818 · info@manshavimpex.com
Manshav Impex exports ISO 13485–certified, EN 13795–compliant disposable surgical drapes from India — AAMI Level 2, 3, and 4 variants, C-section and orthopaedic procedure packs, and custom OEM sets — from USD 0.35 per drape FOB Nhava Sheva, MOQ 500 packs, 21-day lead time, full dossier in 72 hours.
| Parameter | Detail |
|---|---|
| Products | Universal drapes, fenestrated drapes, C-section packs, orthopaedic drape sets, custom procedure packs |
| Material | SMS (spunbond-meltblown-spunbond), SMMS, reinforced critical zones |
| Standards | EN 13795 (Standard & High Performance), AAMI PB70 Level 2 / 3 / 4 |
| Certifications | ISO 13485, CE Mark, WHO-GMP compliant manufacturing practices |
| HS Code | 6307.90 (disposable non-woven surgical drapes, made-up textile articles) |
| MOQ | 500 packs per SKU; mixed-SKU containers accepted |
| Lead Time | 21 days ex-works Surat, Gujarat |
| Dossier Turnaround | 72 hours (CFS, EN 13795 test reports, MSDS, IFU in English/French/Arabic/Spanish) |
| Incoterms | FOB Nhava Sheva / CIF any major port |
| Payment | 30% advance, 70% against BL copy; LC at sight for orders above USD 30,000 |
| OEM / Private Label | Yes — from 2,000 packs, custom print and barcode |
Most procurement teams know AAMI Level 1–4 exists. Fewer know exactly what to specify, and Indian distributors have been known to supply Level 2 against a Level 3 tender spec without flagging the substitution.
Level 2 is appropriate for low-fluid-risk procedures: minor orthopaedic, dental, routine laparoscopic setups. Level 3 is the correct baseline for most general surgery and gynaecology. Level 4 — the highest barrier, rated for prolonged fluid-intensive procedures — is required for vascular surgery, open abdominal work, and any theatre protocol where bloodborne pathogen exposure is a material risk.
Manshav supplies all four levels and will confirm the specific test data (hydrohead pressure, MVTR, liquid strike-through) for each on request. If your tender specification says Level 3, we send Level 3 — not a substitution with a covering note.
Is it realistic to get Level 3 EN 13795 Standard Performance drapes at USD 0.45–0.65 per unit FOB India? Yes. That's the landed economics when you cut out two distribution layers.
| Product | Manshav FOB India | EU/US Distributor Street (indicative) |
|---|---|---|
| Universal drape, 200×300 cm, SMS Level 2 | USD 0.35–0.45/unit | USD 1.20–2.00/unit |
| Fenestrated drape, 75×90 cm, Level 3 | USD 0.45–0.65/unit | USD 1.50–2.80/unit |
| C-section procedure pack (Level 3, 8-piece) | USD 3.20–4.50/pack | USD 12.00–18.00/pack |
| Orthopaedic hip/knee pack (Level 3, 10-piece) | USD 4.00–5.50/pack | USD 14.00–22.00/pack |
| Full-body reinforced Level 4 drape | USD 1.10–1.60/unit | USD 4.50–7.00/unit |
*EU/US distributor prices are open-market benchmarks sourced from public procurement databases; Manshav's own figures are FOB ex-Nhava Sheva.*
Here's what most exporters won't tell you: the resistance to switching from a branded European drape supplier is almost never about clinical performance — it's about paperwork. Procurement managers fear that an Indian product won't come with the documentation stack needed for a Ministry of Health audit or a NAFDAC/PPB registration.
Manshav closes that gap in 72 hours. A standard dossier for surgical drapes includes CE Declaration of Conformity, EN 13795 test reports (ISO 16603, ISO 16604, EN 868-2), ISO 13485 certificate, MSDS, IFU translated into the buyer's regulatory language, and a CFS. The same stack that EU brands charge you four to eight weeks to produce is ready before your LC has been opened.
What can a hospital group realistically save? A 300-bed facility consuming 8,000 procedure packs annually at USD 14.00 EU street price pays USD 112,000/year. At USD 4.00 FOB India plus USD 1.20 freight and duty, landed cost is approximately USD 41,600. That's a saving of over USD 70,000 — enough to fund a full biomedical equipment maintenance contract for the year.
Manshav doesn't only sell catalogue drapes. For hospital groups and distributors who want to reduce theatre setup time and carry a private-label product, we offer custom procedure pack assembly:
The procedure pack business is where distributor margin is highest and where the India price advantage is sharpest. A custom 8-piece C-section pack from a branded European supplier typically runs USD 15–20 per pack. Ours land in Mombasa or Lagos at USD 5.50–7.00 all-in.
Surgical drapes fall under Class I (non-sterile) or Class Is (sterile — special) under EU MDR 2017/745, depending on the regulatory framework. Key registration pathways Manshav has supported:
If your target market isn't on this list, send us the regulatory agency name and we'll confirm dossier availability within 24 hours.
The fastest evaluation path is a mixed sample set — 10 units each of your three most-used drape SKUs (universal, fenestrated, C-section or orthopaedic pack), CIF your port, within 7–10 business days. Full order lead time is 21 days after proforma acceptance.
Enquiry form · Surgical Drapes product page · Download catalogue · WhatsApp +91 84601 91818 · info@manshavimpex.com
EN 13795 Standard Performance is the baseline for most general and gynaecological procedures. If your theatre protocol covers procedures longer than two hours with significant fluid challenge, specify High Performance — Manshav supplies both. We'll confirm the test data (ISO 16603 hydrostatic resistance ≥20 cmH₂O for Standard; ≥100 cmH₂O for High Performance) with the sample.
Yes. Surgical drapes, lap sponges, gowns, and other SMS consumables can ship in the same FCL or LCL container. Mixed-SKU containers are a standard part of how we work — one consolidated shipment reduces your freight cost and customs clearance complexity.
Sterile drapes are ETO-sterilised, validated to a minimum five-year shelf life from manufacture date, and packaged to ISO 11607 sterile barrier requirements. Each pack carries a lot number, sterility indicator, and expiry date. We can provide the sterilisation validation report as part of the standard dossier.
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