Malaysian Rubber Council
Sterile Surgical Gloves
Anatomical, powder-free gloves packed in pairs and EO sterilised
Medical devices
Surgical gloves are the most tightly specified item in the Malaysian rubber portfolio. Malaysian plants produce anatomical, curved-finger gloves with a polymer inner coating, packed as pairs in wallets and sterilised by ethylene oxide to a sterility assurance level of 10 to the minus six.
The council's role is to keep buyers and hospital groups in touch with factories that hold an active technical file, because a surgical glove is a Class IIa device in Europe and changing manufacturer means re-verifying the whole dossier.
Typical applications
- General and orthopaedic surgery
- Obstetric and gynaecological procedures
- Cardiac catheterisation laboratories
- Ophthalmic microsurgery
- Veterinary surgery
Specification
Sterile Surgical Gloves: tolerances and packing
Figures below are typical production limits. Confirm the revision on the factory certificate before a tender is submitted.
| Length | 265 mm and 300 mm |
|---|---|
| Design | Anatomical, curved fingers, beaded cuff |
| Palm thickness | 0.17 mm nominal |
| Tensile strength | 24 MPa minimum before ageing |
| Elongation at break | 750% minimum |
| Sterilisation | Ethylene oxide, SAL 10 to the minus 6 |
| Powder | Powder-free, polymer coated inside |
| Sizes | 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 |
| Packing | Pair packed in wallet; 50 pairs per carton |
| Reference standards | EN 455, ASTM D3577, ISO 10282, MDR 2017/745 Class IIa |
Packing and handling. Wallets are double-wrapped and gamma or EO indicator labels are applied per carton. Transport cartons are designed to protect sterility through tropical transit.
Send a brief, get a shortlist
Product family, annual volume, destination port and the standard your market requires. That is enough for a first shortlist of verified factories.