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Laboratory Test Request

Medical Gowns FDA Level 3 Testing for 510K Filing

Project Description

MULTIPLE TESTS
Medical Device Laboratory needed for medical gowns testing to FDA Level 3 to file our 510(K). 16 CFR, Part 1610, TM127-2017 (2018) e, TM42-2017e, ISO 9073-10, ASTM D5034-09, ASTM D5587-15, ASTM C522, ISO 10993-5:2009, ISO 10993-10:2021,

Project Information

Number:22-01871

Industry:Medical, Surgical and Isolation Gowns

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Other medical, surgical and isolation gowns laboratory services.

Other Medical, Surgical and Isolation Gowns testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :

  • AAMI PB70 testing for fluid resistance Testing
  • ASTM F1670: Resistance to synthetic blood penetration Testing
  • ASTM F1671: Resistance to blood-borne pathogens Testing
  • ISO 16603 and ISO 16604: Resistance to synthetic blood and viral penetration Testing
  • Tensile strength testing Testing
  • Tear resistance testing Testing
  • Seam strength testing Testing
  • Barrier protection testing Testing
  • Flammability testing Testing
  • Biocompatibility testing Testing

Learn more about medical, surgical and isolation gowns testing and research

Medical Devices,Medical Devices - Sterile,Medical Disposables,Medical, Surgical and Isolation Gowns,

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