In our Classification and Grouping Ultimate Guide, we have explained how to classify and group medical devices according to the 23 rules detailed in the Appendix II of the Supplement of medical devices of the Mexican Pharmacopeia (FEUM).
In addition, we have also explained how to make use of those rules to classify and group specific medical devices such as orthopedic implants, ultrasound systems , in vitro diagnostics, facemasks, surgical instruments, and others. In this text we will explain the general characteristics of medical gloves and strategies to classify and group this product in Mexico.
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 to contaminate 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: usually comes in general sizes such as large, medium, and small. These type of gloves are used for routine activities that does not require precision and can be found sterile or non-sterile.
- Surgical gloves: are found in more precise sizes such as extra-small, extra-large, and other standards to better fit the hands of the user. These kind of gloves are used in surgical procedures and thus provide more precision and sensitivity to handle surgical instruments. Surgical gloves are generally sterile.
Classification according to the level of risk in Mexico
All gloves for medical use are considered Class II according to rule 4 of the Supplement of medical devices of the Mexican Pharmacopeia. 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 following these rules:
- The gloves must be made by the same manufacturer
- All models must have same distinctive name or trademark
- The indication of use must be the same (surgical or examination gloves)
- The materials must be the same
- Different size, color, powder can be grouped
- Sterile gloves must be separated from non-sterile
Additional considerations
Gloves for general purpose or multipurpose, including those used for laboratories, and when no interaction with patients or tissues is involved, do not require sanitary registration. This kind of gloves are not considered medical devices as mentioned in the agreement of non-regulated products.
If you have additional questions for classifying and grouping your gloves for sale in Mexico, please contact us at contact@veraqueconsulting.com
