Surgical masks & respirators (N95, FFP2)

Form: Surgical masks, Respirators (N95, FFP2)

Strength: NIOSH-approved N95 masks; filtration efficiency ≥95%; fluid resistance

Reference Brands: 3M, Honeywell, Moldex, Kimberly-Clark

Category: Medical Devices

Surgical masks and respirators (N95, FFP2) are regulated in the US and EU, supported by dossiers demonstrating safety, filtration efficiency, and manufacturing quality compliant with GMP and MDR standards. In the US, NIOSH approval confirms filtration ≥95%, while in the EU, CE marking certifies conformity with in vitro diagnostic and PPE regulations. These products undergo validation, stability testing, and rigorous audits, with detailed documentation including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees the availability of reliable, protective masks vital for healthcare, veterinary, and public health safety worldwide.