TNE International is an FDA-registered Initial Importer for Medical Devices (Registration Number 3008342449). Our company offers a range of different PPE product (N95 Respirators, Patient Exam Gloves, Isolation Gowns, Face Shields, etc…) that have various levels of FDA Approval. Each product is identified clearly with regard to its FDA approval level via the Product Description Sheet and Price Sheet.
Full FDA Approval: Most product is fully FDA Approved, including 510K pre-approval if required.
EUA FDA Approval: During this critical period of PPE shortages, the FDA has allowed Non-FDA Approved product to be manufactured, imported, and used by front line health care workers via different Emergency Use Authorizations (EUA) that define a temporary regulatory framework. Our company also offers PPE that, though not fully FDA Approved, meet the regulatory framework of the various EUA’s, including EUA registration and listing when required.
TNE International’s 20 years of expertise in supplying highly- regulated product from foreign manufactures and managing the reliable quality, delivery, and logistics required have been applied to be a reliable Supplier for PPE.
The download below provides details of the current PPE offering by our company.