MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Center for Devices and Radiological Health (CDRH), in order to determine if there are existing small business sources capable of providing a Protective Clothing Blood Penetration Resistance Tester. Other than small business concerns, especially vendors who may be able to offer domestic products are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov. Background: The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Winchester Engineering and Analytical Center Laboratory (WEAC), requires the purchase of one (1) Protective Clothing Blood Penetration Resistance Tester to support future regulatory testing. The Protective Clothing Blood Penetration Resistance Tester will be used to perform a verification method to test for viral penetration of level 4 medical gowns at the request of CDRH. Level 4 medical gowns provide the highest level of protection against bloodborne pathogens; they are critical in protecting healthcare workers used during risk medical procedures. The gold standard in testing is performed manually and takes specific expertise and an excess of 100 hours to complete. This automated tester would cut hands on time by 75% while increasing consistency and repeatability to the test. Minimum Technical Requirements: Shall provide four (4) independent working positions capable of running four individual tests simultaneously. Shall include an automatic timer capable of initiating and terminating testing without manual intervention. Shall accommodate test samples with minimum dimensions of 70 mm × 70 mm. Shall be capable of achieving a minimum test pressure of 13.8 kPa. Shall provide real-time pressure monitoring during testing. Shall automatically monitor and adjust pressure throughout the test cycle. Shall operate using compressed air. Shall include autoclavable test cells. Shall be capable of processing a minimum of 60 mL of fluid in each test cell. Shall include an integrated touchscreen user interface. Shall be capable of performing testing in accordance with ASTM F1670 and ASTM F1671/F1671M standards. Additional System Requirements : The components and equipment shall be newly manufactured, not us…