Antisepsis, Medical Devices & Consumables

Infection-prevention consumables and single-use medical devices supplied alongside our pharmaceutical range, so a programme can source the medicine and the means to deliver it safely from one supplier.

11 products Chlorhexidine solution · disposable syringes and IV sets · nitrile gloves · masks · adhesive tape · fetal head suction · CGMS · contrast media
4 sourced statements Reference: WHO Model List of Essential Medicines, 24th List (September 2025) Reviewed 2026-10-05

Section 15.1 of the WHO Model List carries chlorhexidine solution 5% digluconate among antiseptics, alongside ethanol 70% and povidone iodine. For newborn cord care, section 22.7 lists a different specification entirely: chlorhexidine 7.1% digluconate delivering 4% chlorhexidine.

At a glance

  • Chlorhexidine 5% digluconate is listed among antiseptics in section 15.1 of the WHO Model List.
  • WHO has recorded more than 40 cases since 2015 of serious eye injury where chlorhexidine was mistaken for an eye preparation.
  • WHO recommends container designs that distinguish chlorhexidine from other medicines used for newborns.
  • MSF prefers the 3 g single-dose cord-care presentation over the 20 g tube to limit contamination.
  • Contrast agents such as iopamidol are regulated as medicines, not devices.

01What the published guidance says

Every statement below is drawn from WHO or MSF published material and linked to its source. We summarise; we do not reproduce. Statements marked as our own are commercial positions, not clinical guidance.

Chlorhexidine is an EML antiseptic, and its concentration matters

Section 15.1 of the 24th WHO Model List (2025) carries chlorhexidine solution 5% (digluconate) among antiseptics, alongside ethanol 70% and povidone iodine. For newborn cord care, section 22.7 lists a different specification entirely: chlorhexidine 7.1% digluconate delivering 4% chlorhexidine. These are not interchangeable products.

WHO has issued a global alert on chlorhexidine misadministration

WHO has recorded more than 40 cases since 2015 of serious eye injury, including blindness, where chlorhexidine gluconate 7.1% was mistaken for an eye drop or ointment. Its recommendations include selecting container designs that distinguish the product from other medicines typically used for newborns, updating the label with safe-use information, and developing clear instructions for users.

MSF's handling rules for cord-care chlorhexidine

MSF specifies the 7.1% gel for the umbilical cord only, states it must not be used on other parts of the body, warns against combining it with soap or other antiseptics such as povidone-iodine because of incompatibility, and notes the 3 g single-dose presentation is preferred over the 20 g tube to reduce contamination from opened tubes.

Diagnostic contrast media are listed medicines

The Model List includes diagnostic medicines such as barium sulfate and meglumine iotroxate — a reminder that contrast agents, including our iopamidol injection, sit inside the medicines regulatory framework rather than the device framework.

02Products in this therapeutic group

Each entry links to its full specification page.

Products supplied by Sinophare Bio-technology Co., Ltd. in the Devices & Antisepsis therapeutic area
Product Dosage form Presentation notes Detail
2% Chlorhexidine Gluconate solution Medical Device   View 2% Chlorhexidine Gluconate solution →
60ml physiological seawater nasal spray Medical Device   View 60ml physiological seawater nasal spray →
Iopamidol Injection 300mgI/mL 100ml Injection   View Iopamidol Injection 300mgI/mL 100ml →
Disposable nitrile gloves are powder-free Medical Device   View Disposable nitrile gloves are powder-free →
Disposable Fetal Head Suction Device Medical Device   View Disposable Fetal Head Suction Device →
Disposable Medical Mask Medical Device GMP Standard 3 Ply Protective Mask View Disposable Medical Mask →
Medical Adhesive Tape is breathable Medical Device   View Medical Adhesive Tape is breathable →
infusion set Medical Device   View infusion set →
Disposable syringe is sterile Medical Device   View Disposable syringe is sterile →
Understanding Continuous Glucose Monitoring System (CGMS) Medical Device   View Understanding Continuous Glucose Monitoring System (CGMS) →
Infusion IV sets are sterile disposable Medical Device   View Infusion IV sets are sterile disposable →

11 products in this group · part of 186 finished dosage forms across 14 therapeutic areas.

03Specifying your order

The five things worth stating on a purchase order for this group, so the quotation comes back right first time.

Chlorhexidine specification

State the concentration and the indication. General antiseptic chlorhexidine and cord-care chlorhexidine are different products.

Container differentiation

If you distribute both chlorhexidine and ophthalmic products, specify container shape, colour and labelling that cannot be confused.

Sterility assurance

For single-use sterile devices, state the sterility assurance level and the packaging integrity documentation your market requires.

Size and grade

Glove size and material, syringe volume and needle gauge, tape width — specify all three rather than a product family name.

Diagnostic contrast

For iopamidol, confirm that injectable-grade analytical documentation, not device documentation, accompanies the batch.

04How we supply it

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

Infection prevention

Chlorhexidine gluconate solution and alcohol-based hand hygiene products.

Single-use devices

Disposable syringes, sterile infusion and IV sets, powder-free nitrile gloves, 3-ply medical masks and breathable medical adhesive tape.

Clinical devices

Disposable fetal head suction devices and continuous glucose monitoring systems.

Diagnostics

Iopamidol injection 300 mgI/mL for contrast imaging, supplied with the analytical documentation appropriate to an injectable medicine.

05Safety, labelling & regulatory notes

Points worth carrying into your tender, label review or clinical briefing.

  • Never allow a chlorhexidine product to be confused with an eye preparation. WHO has documented more than 40 cases of serious eye injury, including blindness, from this exact error. Container design and labelling are patient-safety controls, not marketing choices.
  • Cord-care chlorhexidine is a different concentration from general antiseptic chlorhexidine solution. Confirm which specification you are ordering.
  • Contrast media such as iopamidol are injectable medicines and require the documentation of an injectable medicine, not that of a device.
  • Confirm the sterility assurance level and packaging integrity requirements for your market for every single-use device in this range.

06Questions buyers ask

6 answers covering specification, documentation and regulatory questions for this group.

What chlorhexidine specifications do you supply?
Both the 2% chlorhexidine gluconate solution used as a general antiseptic and the 7.1% digluconate cord-care gel delivering 4% chlorhexidine specified in section 22.7 of the Model List. These are different products for different indications.
Why do you highlight the WHO chlorhexidine alert?
Because container confusion between chlorhexidine and eye preparations has caused more than 40 cases of serious eye injury including blindness. Selecting a visually distinct container is a WHO recommendation and we treat it as a specification, not an afterthought.
Do single-use devices come with sterility documentation?
Yes. Sterile single-use devices are supplied with sterility assurance documentation and packaging integrity confirmation in the format required for your market.
Is iopamidol regulated as a medicine or a device?
As a medicine. WHO lists contrast agents such as barium sulfate and meglumine iotroxate among diagnostic medicines, and we supply iopamidol with injectable-grade analytical documentation.
Why do you treat chlorhexidine container design as a specification?
Because WHO has recorded more than 40 cases of serious eye injury, including blindness, where chlorhexidine was mistaken for an eye drop. WHO recommends container designs that distinguish the product, so we treat that as a requirement rather than a preference.
Can we order medicines and consumables on one purchase order?
Yes. Sourcing both from one supplier means one documentation set, one shipment and one point of accountability for a programme.

07Related therapeutic areas

Adjacent groups you may want to combine on one purchase order.

Request a quotation for Devices & Antisepsis

Send us the products, strengths and pack sizes you need, together with the destination country, and we will return a quotation with the documentation package and lead time. Registration support documents are provided with every order.

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Or write to info@sinophare.com