Protective Clothing Blood Penetration Resistance Tester

The U.S. Food and Drug Administration (FDA) is seeking information from potential vendors who can provide a Protective Clothing Blood Penetration Resistance Tester. The tester will be used to support future regulatory testing and will be required to meet specific technical requirements, including the ability to perform four independent tests simultaneously and to achieve a minimum test pressure of 13.8 kPa. The tester will be used to test level 4 medical gowns for viral penetration resistance. • The tester must provide four independent working positions capable of running four individual tests simultaneously. • The tester must include an automatic timer capable of initiating and terminating testing without manual intervention. • The tester must accommodate test samples with minimum dimensions of 70 mm x 70 mm. • The tester must be capable of achieving a minimum test pressure of 13.8 kPa. • The tester must provide real-time pressure monitoring during testing. • The tester must automatically monitor and adjust pressure throughout the test cycle. • The tester must operate using compressed air. • The tester must include autoclavable test cells. • The tester must be capable of processing a minimum of 60 mL of fluid in each test cell. • The tester must include an integrated touchscreen user interface. • The tester must be capable of performing testing in accordance with ASTM F1670 and ASTM F1671/F1671M standards.