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A US medical glove approved by FDA

Finding the right healthcare gloves has never been so important. For the medical and healthcare sector, the choice is essential.
When working in the healthcare industry you need medical grade gloves, which means that the glove has been labeled for application in the medical field. Our gloves are FDA medical approved. The FDA has reviewed these gloves and have been deemed as Class I reserved medical device that requires a 510(k) premarket notification. A designation that ensures gloves meet performance criteria such as leak resistance, tear resistance and biocompatibility.

With a history of 50 years producing Made-in-America gloves, our factory in Fayette is cleared to produce medical gloves.

Contact us if you want to see how made-in-America gloves are saving Americans lifes.

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FDA approved

Submitted in 2021, the FDA gave us the 510(l) approval. Our factory in Fayette, Alabama, is now cleared to produce gloves proofed to be safe and effective for medical examination. Check below the full approval decision.

CHECK THE FDA CERTIFICATION
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Up to 2.9 billion single-use gloves by 2024

Our extension plan is continuing in Fayette. After opening a state-of-the-art production line in October 2021, 3 other lines are raising from the ground. The goal is to be able to produce 2.9 billion single-use gloves by the end of 2024.

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