In our Device Classification and Grouping Guide, we have explained how to classify and group medical devices in Colombia according to the 18 rules detailed in the article 7 of the Decree 4725 of 2005 .
In addition, we have also explained how to make use of those rules to classify and group specific medical devices such as surgical instruments, ultrasound systems, in-vitro diagnostics and others. In this text we will explain the general characteristics of medical gloves and strategies to classify and group this product in Colombia.
General characteristics of medical gloves
When considered for healthcare purposes, the main use of gloves is helping to prevent cross-contamination between healthcare professionals and patients. In other words, gloves prevent those microorganisms in the hands of the physicians from contaminating the tissue of the patient. At the same time, it protects the caregiver from the microorganisms of the patient.
Most gloves for medical use are disposable and can be made from different materials (e.g. latex, nitrile, polyvinyl to neoprene and other polymers). Gloves may come powered (lubricated) with talcum or unpowered corn starch.
There are two main classifications of gloves for medical use:
- Examination gloves: also known as inspection gloves, are medical devices made for single use. They are used in medical applications and not medical measures. Additional to preventing cross-contamination they are used to prevent direct contact with substances (chemicals and solutions) with the user’s skin. They can be found sterile or non-sterile.
- Surgical gloves come in more precise sizes such as extra-small, extra-large, and other standards to better fit the hands of the user. Surgeons use these types of gloves in surgical procedures, which provide more precision and sensitivity for handling surgical instruments. Surgical gloves are generally sterile.
Classification according to the level of risk in Colombia
Both examination and surgical gloves, are considered Class IIa according to rule 6 of the Decree 4725 of 2005. The material characteristics, powder, sterility, and use do not change this classification of risk.
Grouping for Sanitary Registration purposes
Different models of gloves can be included in the same Sanitary Registration in Colombia, following these rules:
- The gloves must belong to the same device classification.
- The same manufacturer must make the gloves.
- All models must have the same intended use (surgical or examination gloves) and generic name.
- Differences in terms of properties, size or characteristics that do not significantly modify their indication can be grouped.
If you have additional questions for classifying and grouping your gloves for sale in Colombia, please contact us at contact@veraqueconsulting.com
