The Difference is the Quality

Since 1988, MICROFLEX®Corporation has been recognized as the quality leader among thin-film hand protection providers. MICROFLEX® brings an innovative approach to the glove market. They design specific gloves for specific needs to help professionals do their job better and consistently protect them.

Quality is the Key – ISO 13485 certified

In addition to complying with the FDA Quality System Regulation (QSR), MICROFLEX® is THE ONLY glove manufacturer that is ISO 13485 registered. This quality assurance sets MICROFLEX® apart from the competition.

ISO 13485 requirements reach beyond the normal quality system standards of FDA, QSR, and ISO 9000 that are employed by competitors.

These standards are required by the Medical Device Directive of the European Union when an organization needs to demonstrate its ability to provide medical devices and related services.

ISO 13485 standards ensure that products consistently meet quality standards along with customer and regulatory requirements.

MICROFLEX® gloves meet medical glove standards from ASTM International and the FDA.

The MICROFLEX® Quality System

The MICROFLEX® Quality System is just that – a System. What does this mean for MICROFLEX® customers and partners when they choose MICROFLEX® products?

Customers receive one of the best gloves on the market with service and support from a company that adheres to a higher standard of quality.

All gloves meet ISO 13485 requirements, which include more stringent details regarding technical files, complaint handling, work environments, risk analysis, identification, traceability, and record retention.

MICROFLEX® goes to extraordinary lengths to ensure the quality of its products. The MICROFLEX® Management Team meets every six (6) months to assess the metrics and performance of the Quality System. They are committed to constantly looking for ways to improve the quality of their products to ensure better-performing products for our customers. On a daily basis, glove performance is tested at MICROFLEX®'s in-house laboratory, and this data is used to continually improve the performance, safety, and reliability of MICROFLEX® products.

MICROFLEX® is also continuously searching for ways to improve its Service Quality. They have implemented the C.A.R.E. customer complaint management program, designed to answer customers' questions and concerns relating to product quality and technical information.

The company has a team to help customers who had negative reactions or received a product they didn't like. They are trained to assist.

MICROFLEX® Participation in C-TPAT

MICROFLEX® is a voluntary member of the Customs-Trade Partnership Against Terrorism (C-TPAT) joint initiative with the Department of Homeland Security designed to build cooperative relationships that strengthen the overall supply chain and border security.