PERSONAL PROTECTIVE EQUIPMENT (PPE)
Northfield Medical Manufacturing is an FDA-registered importer, re-packager and distributor of PPE products, including masks, respirators, isolation gowns, coveralls, goggles, face shields and medical exam gloves. Whether your needs are very large or more modest, Northfield is well positioned to partner with your organization to satisfy your PPE needs. Our current customers include state and local government agencies, regional healthcare systems and educational institutions.
NIOSH N95 and KN95
ASTM Level 1 and ASTM Level 2
CPE/AAMI; PP+PE Coated PP Material AAMI and SMS Non-Woven
Medical Exam Gloves
Nitrile and Vinyl
Northfield sources certified personal protective equipment from both US based and overseas manufacturers. Domestically, we have strong relationships with branded N95 mask distributors and nitrile glove and medical equipment manufacturers. In the cases where overseas sourcing is the best option, our customers benefit from Northfield’s expertise as it relates to quality assurance and certification, customs clearance and transit options.
International PPE Sourcing
Product Quality Assurance & Importing Standards
Most PPE falls within FDA's “Class 1” device category, and the FDA doesn’t certify Class 1 items. Instead, the FDA establishes product standards for Class 1 devices (isolation gowns, exam gloves, procedure masks, face shields, etc.). Northfield only sources PPE product from factories with active FDA registrations and deliver products that comply with such FDA Class 1 standards. Our Quality Control agents on the ground in various regions of China inspect factories and finished goods before accepting products for export.
Most “Class 2” FDA items we import come from factories that have been FDA-certified for such products (for instance, chemo-rated gloves, surgical masks, and NIOSH N95 masks).
We declare all medical imports with the FDA via our import filings, and we gain pre-clearance from the FDA before goods pass through U.S. Customs.
We offer dedicated space on shipping containers, commercial cargo holds and private chartered flights. We are experts at securing and handling freight from its point of origination all the way to the point of delivery. We have nimbly adapted to the rapid foreign government export rule changes, to the FDA on EUA lists, and to the skyrocketing commercial air cargo rates to protect our customers and deliver the goods on budget and on time.
A good rule of thumb is that short lead times (< 4 weeks) typically require commercial air cargo or private chartered flights. Longer lead times (4-8 weeks) allow us to use container ships.