Brazil Proposes Minimum Quality Standards for Surgical and Non-Surgical Gloves made of rubber and PVC

The Brazilian Health Regulatory Agency (ANVISA) has issued a notification regarding the proposal of a new rule to establish minimum identity and quality requirements for surgical gloves and gloves used in non-surgical procedures. The notification, made in accordance with Article 10.6, aims to protect human health and safety by ensuring the quality of healthcare technology.

Under the proposed draft resolution, which is currently available for public consultation, the regulation would cover surgical gloves and gloves made of natural rubber, synthetic rubber, a mixture of natural and synthetic rubbers, and polyvinyl chloride. The minimum quality requirements would be enforced under a health surveillance regime.

Notification: G/TBT/N/BRA/1485

Objective tag
Protection of human health or safety (TBT)

Documents

• CONSULTA+P%C3%9ABLICA+N+1161+GEMAT.pdf