3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant)
Certified 3-layer surgical face mask featuring high-efficiency meltblown filter media (BFE ≥ 98%, PFE ≥ 98%), malleable nose bridge, and ultrasonic welded soft ear loops or surgical head ties.
3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant) is exported by Manshav Impex, an Indian manufacturer & exporter, and produced at vetted, ISO 13485-certified partner factories to CE MDR, ISO 13485, EN 14683 Type IIR, ASTM F2100 Level 3 (HS Code: 6307.90). 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 200,000 pcs (lead time: 10–16 days).
Technical details
| Layer Structure | Outer Spunbond (Fluid-repellent) + Middle Meltblown Filter + Inner Spunbond |
| Filtration Performance | BFE ≥ 98% (Bacterial Filtration) & PFE ≥ 98% (Particulate Filtration) |
| Classification | EN 14683 Type II & Type IIR (Splash resistant up to 120 mmHg) |
| Differential Pressure | < 40 Pa/cm² (Type II) / < 60 Pa/cm² (Type IIR) highly breathable |
| Attachment | Ultrasonic welded elastic ear loops / Surgical head ties |
| Nose Wire | Fully enclosed plastic-coated aluminum wire |
| Colors Available | Hospital Blue, Green, White, Black |
| Standard | EN 14683:2019 / ASTM F2100 / ISO 13485 |
| Packaging | 50 pcs/dispenser box · 40 boxes/carton (2,000 pcs/master carton) |
| HS Code | 6307.90 |
Where it's used
- Surgical Operating Theatres & Scrub Suites
- Hospital Inpatient & Outpatient Departments
- Dental Clinics & Isolation Wards
- Public Health Disease Containment Programs
Official TDS, CoA & Regulatory Compliance for 3-Ply Surgical Face Mask
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 3-Ply Surgical Face Mask
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 3-Ply Surgical Face Mask
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 3-Ply Surgical Face Mask
In-depth regulatory analyses, material comparisons, and international hospital procurement frameworks authored by Manshav Impex trade specialists.
Procurement FAQs for 3-Ply Surgical Face Mask
Essential details regarding bulk ordering, sample requests, quality testing, and global export shipping.
What is the HS code for 3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant) exported from India?
3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant) is exported under HS heading 6307.90. 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 3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant)?
Layer Structure: Outer Spunbond (Fluid-repellent) + Middle Meltblown Filter + Inner Spunbond; Filtration Performance: BFE ≥ 98% (Bacterial Filtration) & PFE ≥ 98% (Particulate Filtration); Classification: EN 14683 Type II & Type IIR (Splash resistant up to 120 mmHg); Differential Pressure: < 40 Pa/cm² (Type II) / < 60 Pa/cm² (Type IIR) highly breathable; Attachment: Ultrasonic welded elastic ear loops / Surgical head ties. Export packing: 50 pcs/dispenser box · 40 boxes/carton (2,000 pcs/master carton). Full technical data sheets are shared with every quotation.
What is the Minimum Order Quantity (MOQ) and lead time for 3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant)?
The standard MOQ for 3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant) is 200,000 pcs with an estimated production and export dispatch lead time of 10–16 days. We also accommodate trial shipments and mixed-container orders for hospital networks and distributors.
Which quality certificates and test reports accompany 3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant)?
3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant) is produced at a vetted, ISO 13485-certified partner factory in India and made to CE MDR, ISO 13485, EN 14683 Type IIR, ASTM F2100 Level 3 (HS Code 6307.90). 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 3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant) 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 3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant)?
Yes, we arrange complete OEM and private-label programs for 3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant) through our partner factories, including custom artwork, barcode labeling, language-specific inner boxes, and bulk export packaging (50 pcs/dispenser box · 40 boxes/carton (2,000 pcs/master carton)).
What export shipping and payment terms are available for 3-Ply Surgical Face Mask (Type II & Type IIR Fluid Resistant)?
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 3-Ply Surgical Face Mask
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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