QARA CG is committed to responding to a growing and urgent need throughout the United States for critical Personal Protective Equipment (PPE), including N95 masks (Industrial and Medical), Gowns, Surgical Masks, Nitrile Gloves, Protective Face Shields, Thermometers, and lab supplies due to the Coronavirus outbreak.

QARA CG can enable the export of Personal Protective Equipment (PPE) by expediting FDA registration and providing mandatory U.S. Agent services. We will also act as your FDA Official Correspondent for 2020 at no additional charge.

 

Manufacturers of any of the following products can complete and submit the FDA Establishment Form linked below immediately to begin FDA registration.

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• N95 Masks

• KN95 Masks

• Surgical Masks

• Nitrile Gloves (all sizes)

• Protective Face Shields

• Single-Use Thermometers

• Lab Supplies

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QARA CG is committed to supporting manufacturers of PPE beyond 2020, and can provide continued FDA representation as a U.S Agent and FDA Official Correspondent beyond 2020 for an annual fee. 

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Manufacturers of other medical devices should contact QA/RA Consulting Group at info@qaraconsultinggroup.com. An Industry Consultant will reply to all other requests in the order in which they are received.