Group 05

Sterile single-use products

Syringes, needles, cannulas, catheters, infusion sets, examination and surgical gloves, gowns, drapes and medical face masks.

HS 9018.31
HS 9018.32
HS 9018.39
HS 4015.12

This group contains the products a healthcare facility consumes most: syringes, needles, cannulas, catheters, infusion sets, gloves, gowns, drapes and masks. With high volumes and low unit prices, a small difference in quality can turn into a big problem. That is why we start manufacturer selection with documents and samples, not with price.

For sterile products, the sterilisation method (ISO 11135 for ethylene oxide, ISO 11137 for radiation), the lot sterilisation record and the expiry date are the key checkpoints. For products sterilised with ethylene oxide, we also ask about the destination country's residue requirements, and for gloves, about powder and latex. Compliance of the label with the destination country's language requirements is settled at the order stage.

Products we supply in this group

Single-use syringes and insulin syringes
Hypodermic needles and blood collection needles
Intravenous cannulas
Urinary, central venous and other catheters
Infusion and transfusion sets
Examination and surgical gloves (latex, nitrile)
Surgical gowns and drapes
Medical face masks and respirators
Oxygen masks and nasal cannulas
Urine bags, suction catheters and drainage sets

Who we work for

Hospitals and central purchasing units
Clinics, outpatient centres and dialysis centres
Medical consumables distributors and wholesalers
Companies bidding in healthcare tenders
Suppliers to pharmacies and medical supply stores

Typical HS subheadings

9018.31	Syringes, with or without needles
9018.32	Tubular metal needles and needles for sutures
9018.39	Catheters, cannulas, infusion sets and the like
4015.12	Medical and surgical gloves of vulcanised rubber
6210.10	Gowns and protective garments of nonwoven fabric
6307.90	Face masks and other made-up textile articles

Codes are indicative and follow the HS 2022 nomenclature. The final classification is made for each shipment based on the product's technical characteristics, intended use and the tariff of the destination country.

Documents we request from the manufacturer

Declaration of conformity and, for sterile products, Notified Body certificate
Manufacturer's ISO 13485 quality management system certificate
Sterilisation validation summary and lot sterilisation record
Test reports to product standards such as EN 455 for gloves and EN 14683 for medical masks
Certificate of Free Sale and label samples

Transport and storage notes

Bulky products are usually shipped by sea container, palletised and protected from moisture.

Crushed cartons can damage the sterile barrier packaging; stacking height is limited according to the carton markings.

Latex and nitrile gloves are protected from direct sunlight and excessive heat.

Questions about this group

Can you supply products under our own brand (private label)?

Some manufacturers produce under the buyer's brand. However, under regulations such as the EU MDR, a company placing a product on the market under its own name may take on the manufacturer's responsibilities. For private label requests, we therefore recommend that you first clarify the regulatory consequences on your side.

Can we get documents on ethylene oxide residues?

Yes. For products sterilised with ethylene oxide, we ask the manufacturer for the sterilisation validation summary and residue test results. If the destination country has a specific limit, just let us know before ordering.

How do you prevent differences between the sample and series production?

The catalogue number, packaging and label details of the approved sample are written into the contract. On request, samples taken from series production are compared with the approved sample through independent pre-shipment inspection.

Request a quote for this group

Tell us the product name, model or technical specification, quantity and destination country. If you also list the documents the destination country requires, we will prepare our offer accordingly.

Request a quote