Surgical Gloves (Latex, Nitrile, Vinyl)

Form: Latex gloves (natural rubber), Nitrile gloves (synthetic rubber, latex-free), Vinyl gloves (PVC-based)

Strength: Varying thicknesses

Reference Brands: Ansell, Medline, Kimberley-Clark, Mapa, Dynarex

Category: Medical Devices

Surgical gloves (latex, nitrile, vinyl) are regulated in the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality following GMP standards. In the US, FDA approval involves validation, safety assessments, and compliance with medical device regulations. In the EU, CE marking certifies conformity with in vitro diagnostic and medical device regulations. These gloves undergo validation, microbiological barrier testing, strength, and durability assessments, with extensive documentation including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring adherence guarantees access to safe, reliable surgical gloves for global healthcare and veterinary applications.