Every Nigerian hospital procurement officer who has tried to import nitrile examination gloves from India has hit the same wall: the exporter sends a CE certificate and calls it done, the customs agent asks for a NAFDAC product-registration number, and suddenly a six-month-old enquiry is turning into a twelve-month delay. Here's the part most exporters won't tell you: Nigeria's NAFDAC system will clear an Indian-made nitrile glove shipment faster than almost any other medical consumable on the register — if the exporter knows exactly which documents the Product Registration Directorate actually checks.
Importing nitrile examination gloves from India to Nigeria requires NAFDAC Class A registration (CRIA, 90–120 days), HS 4015.11 with 0% import duty for registered products, AQL 2.5 test reports, and CFS from CDSCO — FOB Nhava Sheva at USD 6.80–14.50 per 100 gloves for 3.5–5.5 mil powder-free.
In short: Importing nitrile examination gloves from India to Nigeria requires NAFDAC Product Registration (Class A medical device, 90–120-day CRIA pathway), HS Code 4015.11 with 0% import duty for registered gloves, a Certificate of Free Sale from CDSCO India, ISO 13485 with a glove-specific scope, and lot-specific AQL 2.5 test reports — FOB Nhava Sheva price runs USD 6.80–14.50 per 100 gloves depending on gauge and pack size.
| Parameter | Detail |
|---|---|
| HS Code | 4015.11 (rubber gloves — surgical/examination) |
| NAFDAC product class | Class A medical device |
| Registration pathway | CRIA (commercial) or MoH Fast-Track (donor/FMoH) |
| Lead time from order | 10–18 days production + 22–28 days sea (Nhava Sheva → Apapa) |
| MOQ | 50,000 pairs (LCL trial) / 200,000+ pairs (FCL, 20 ft) |
| FOB price range | USD 6.80–14.50 per 100 gloves (2.5–5.5 mil gauge, powder-free) |
| Certifications required | ISO 13485, CE Mark (MDR), CFS from CDSCO India, AQL test report |
| Port of entry | Apapa (Lagos) or Tin Can Island |
| Key NAFDAC dossier item | AQL 1.5 pin-hole test report — most common rejection trigger |
Nitrile examination gloves for Nigeria — NAFDAC-ready dossier, lot-specific AQL test reports, 10–18 day production lead time FOB Nhava Sheva. Product page · Full catalogue · Request quote · WhatsApp +91 84601 91818 · info@manshavimpex.com
Nitrile examination gloves are classified as Class A medical devices by NAFDAC's Product Registration Directorate. That sounds straightforward, but the registration paperwork is more demanding than the classification suggests — because gloves are one of the few consumables where NAFDAC reviewers actively cross-reference the product labelling, the AQL test reports, and the ISO 13485 scope document against each other.
The CRIA (Complementary and Alternative Registration Initiative for Accelerated) pathway is the right route for commercial importers. Target 90–120 days for a complete first-time dossier. Two things consistently slow it down: first, mismatched AQL classification — NAFDAC expects examination gloves tested to AQL 2.5 (or AQL 1.5 for surgical). An exporter who submits a generic ISO 11193-1 report without specifying the exact AQL level triggers a query that adds 6–10 weeks. Second, labelling mock-ups without NAFDAC-specific elements — the PRD increasingly requires the label to show both the HS code classification and a 'NOT FOR STERILE FIELD' disclaimer. An exporter using a generic EU market label without those elements will receive a labelling deficiency letter.
Is it really worth fixing these two things before you submit, rather than after? Every importer who has done it once will tell you the same thing: fix them first. The cost is a week of back-and-forth with your supplier. The alternative is three months of re-submission queues at NAFDAC's PRD.
The Fast-Track pathway (4–6 weeks) exists for Federal Ministry of Health procurement lots and for UNICEF- or USAID-funded donor programmes. Your buyer must be a registered FMoH entity. For private hospital groups and commercial distributors, CRIA is the only route.
Nitrile examination gloves enter Nigeria under HS 4015.11 (gloves of vulcanised rubber — examination). Under the ECOWAS Common External Tariff, the standard duty for Chapter 40 rubber articles is 5% CIF. However, examination gloves with NAFDAC registration imported by a licensed distributor qualify for the Essential Medical Consumables exemption, bringing effective import duty to 0% — confirm the current gazette instrument with your licensed clearing agent at the time of shipment. VAT at 7.5% applies on the CIF value regardless. Budget for NAFDAC's inspection levy (0.2% CIF) and the Apapa Pre-Arrival Assessment Report (PAAR) filing fee.
| Cost Line | Amount (USD) |
|---|---|
| FOB Nhava Sheva (500k pairs × ~USD 0.095) | 47,500 |
| Ocean freight (Nhava Sheva → Apapa) | 2,100 |
| Marine insurance (0.4% CIF) | 199 |
| PAAR filing + port handling | 950 |
| NAFDAC inspection levy (0.2% CIF) | 100 |
| Import duty (0% — exempted) | 0 |
| VAT (7.5% CIF) | 3,741 |
| Clearing agent + delivery to Lagos depot | 800 |
| Total landed (Lagos depot) | ~55,390 |
| Unit landed cost | ~USD 0.111 / pair |
A Nigerian distributor buying from a European intermediary typically pays USD 0.18–0.28 per pair at landed cost. The India-direct route delivers the same ISO 13485 CE-marked glove at 40–60% of that cost, with a 22–28 day sea transit that fits a well-planned procurement cycle.
| Factor | What to require |
|---|---|
| ISO 13485 scope | Must name 'examination gloves' or 'disposable medical gloves' specifically |
| AQL test report | AQL 2.5 per EN 455-1 or ASTM D6319, lot-specific, dated within 12 months |
| CFS from CDSCO | Product-specific — must name the glove type and HS code |
| Labelling mock-up | NAFDAC-compliant: HS code, batch/lot, AQL class, 'NOT FOR STERILE FIELD' disclaimer, manufacturer address |
| Shelf life | Minimum 3 years from production date — Nigerian procurement cycles run long |
| MOQ flexibility | Can they do a 50,000-pair LCL trial before full container commitment? |
| Payment terms | TT 30% advance + 70% against BL copy, or LC at sight |
Manshav Impex supplies 3.0–5.5 mil powder-free nitrile examination gloves in S/M/L/XL sizing with lot-specific AQL test reports, NAFDAC-ready labelling templates, and CFS coordination through CDSCO. Typical dossier package delivery is 7 working days from confirmed purchase order. ISO 13485, CE, and WHO-GMP compliant manufacturing practices are standard at our partner facilities in India.
The shift isn't about price alone. Nigeria's private hospital sector — growing at roughly 8–10% annually as federal funding gaps widen — needs supply-chain predictability. An Indian exporter with a confirmed NAFDAC registration on file can ship repeat orders within 15–18 days from order confirmation. A European distributor typically takes 45–60 days for the same volume, at 2–3× the unit price.
The practical question for any Nigerian procurement officer is not whether to shift sourcing — it's which Indian exporter has the NAFDAC paperwork in order before you wire the advance payment. That is the only real due diligence that matters at this stage of the relationship.
Yes, provided the sizes are listed in the same product registration application as size variants of a single product. NAFDAC registers by product type; size variants within the same manufacturing specification can share one registration if the dossier explicitly lists all sizes and the ISO 13485 scope covers them all.
There is no minimum volume threshold for NAFDAC clearance — registration is per product, not per shipment. A 50,000-pair LCL trial can be cleared under the same registration as a full FCL once the product is registered. LCL shipments below roughly 20,000 pairs become economically unattractive once clearing agent fees are factored in.
Yes. Powder-free and powdered variants are treated as distinct products by NAFDAC's PRD — different AQL reports, different labelling requirements, and separate registration dossiers. Most Nigerian hospital tenders now specify powder-free as a mandatory condition, so register the powder-free variant first.
Importing surgical gloves into Ghana requires FDA Ghana Class II registration via the G-FIRMS portal, a licensed Local Agent, and a full technical dossier. Sourcing from an Indian manufacturer cuts landed CIF cost by 50–65% vs European brands with the same CE, ISO 13485 documentation package.
Ansell and Mölnlycke make excellent surgical gloves — but distributor pricing runs 4–8× a CE-marked, EN 455-compliant Indian source. Manshav Impex exports sterile latex and nitrile surgical gloves at FOB USD 0.09–0.22/pair with CE DoC, CFS, and lot traceability.
Kenyan hospitals buying AAMI Level 2/3 surgical gowns through regional distributors pay 35–55% more than the direct factory price from India — with the same CE marking, PPB-compliant documentation stack, and 4–6 week delivery to Mombasa.