
Quality
At Exact Medical, we treat every project with the same unwavering commitment to quality.
Our systematic approach to quality assurance gives Exact Medical the confidence that every step — from material sourcing, validation, production and packaging to delivery — is precise and achieves our customers’ expectations. We can say with confidence we deliver the right product every time.







A singular focus on quality through every production run.
Product Credentials
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- FDA 510(k) Premarket Notification
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- K121919
- K120045
- K111535
- K101598
- K101688
- K101689
- K101593
- K211969
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FDA Premarket Notification meets the AAMI PB:70 Level 1 through 4 standards for Gowns and Drapes.
- FDA 510(k) Premarket Notification
- ISO 10993 Biocompatible
- ISO 11135 Sterilization Validation
- ISO 11607 Packaging for Terminally Sterilized Medical Devices
- AAMI PB:70 Liquid Barrier Compliant
- EN13795 Barrier Compliant (Standard/High Performance)
- 16CFR1610:2007 – Compliant Flammability Rating
- ISO 13485:2016 Quality Management System
- CE certified under Medical Device Regulation

