Classification and Grouping of Gloves in Costa Rica

In our Device Classification and Grouping Guide, we have explained how to classify and group medical devices in Costa Rica based on the 16 rules outlined in Annex A of Decree No. 43902-S 

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 products in Costa Rica. 

General characteristics of medical gloves 

For healthcare applications, gloves primarily function to prevent cross-contamination between professionals and patients. Specifically, they serve as a barrier that restricts microorganisms present on clinicians’ hands from transferring to patient tissues. Additionally, gloves offer protection to caregivers by reducing their exposure to pathogens originating from patients. 

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 Costa Rica 

Both examination and surgical gloves, are considered Class 2 according to Rule 4 of Decree No. 43902-S. 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 Costa Rica, following these rules: 

1. The gloves must belong to the same device classification. 
2. The same manufacturer must make the gloves. 
3. All models must have the same intended use (surgical or examination gloves) and generic name. 
4. Differences in terms of properties, size or characteristics that do not significantly modify their indication of use can be grouped. 

If you have additional questions for classifying and grouping your gloves for sale in Costa Rica, please contact us at contact@veraqueconsulting.com