Get your FDA clearance to market by performing your benchtop testing with us.

Bioana has an ISO 17025 certified testing laboratory that can help you with your mechanical, material and packaging testing to ensure safety and efficacy in your product for FDA regulatory submissions.

We can provide a substantial equivalency testing file for a 510k.  

Standards:

ASTM D3577
Standard Specification For Rubber Surgical Gloves
ASTM D6977
Standard Specification For Polychloroprene Examination Gloves For Medical Application
ASTM D3578
Standard Specification For Rubber Examination Gloves
Is your product a new development and need testing to your specific requirements?

Our R&D department is set up to flexibly react to your testing needs and help you design a customized testing protocol for your device.
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