Laboratory Test Request

FDA GMP Surgical Gown and Hood Sterilization Validation and Testing to Suport FDA 510(k)

Project Description

NEW PRODUCT DEVELOPMENT
MULTIPLE TESTS
MULTILE RODUCTS
FDA GMP Medical Device Laboratory needed for sterilization EO Validation Study and a full suite of tests on new Surgical Gowns and Hoods (biocompatibility testing and performance testing) in order to have sufficient data to submit for clearance of a 510(k). The gowns and hoods will be sterile, so we will need to do sterilization validation as well. I have listed full tests below, let me know what you can or cannot do.


EO Validation Report per AAMI/ISO 11135-1
Residual Test Report per ISO 10993-7
Biocompatibility: ISO 10993-1, ISO 10993-5 and ISO 10993-10: Cytotoxicity, Sensitization & Skin Irritation
Level 4 Viral Penetration - ASTM F1671
Thank you for your time in reviewing my request.

Project Information

Number:21-01091

Industry:Medical Devices

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Personal Protection Equipment (PPE),Safety and Protection Equipment,Medical Devices,Medical Devices (Reusable),Medical Devices - Sterile,Medical Disposables,Medical, Surgical  and Isolation Gowns,Textiles - Medical,Textiles and Fabrics,

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