Protective Clothing Blood Penetration Resistance Tester
The FDA's Office of Acquisitions and Grants Services is conducting market research on behalf of the Center for Devices and Radiological Health to identify sources capable of providing one Protective Clothing Blood Penetration Resistance Tester, with capability statements due by June 23, 2026. This is a market research announcement, not a solicitation or RFP.
The FDA seeks small business concerns under NAICS 334516 (Analytical Laboratory Instrument Manufacturing, 1,000-employee size standard), though vendors of all sizes, particularly those offering domestic products, are encouraged to submit capability statements. Respondents should address company information and demonstrate ability to meet all minimum requirements, including identification of the country of manufacture.
The tester will be procured by and delivered to the FDA's Winchester Engineering and Analytical Center Laboratory (WEAC) to perform verification testing of viral penetration in level 4 medical gowns at the request of CDRH. Level 4 gowns provide the highest protection against bloodborne pathogens for healthcare workers during high-risk medical procedures. The current gold-standard manual testing process requires over 100 hours of hands-on expertise; an automated tester would reduce hands-on time by 75 percent.
Interested vendors should submit capability statements via email to Warren.Dutter@fda.hhs.gov.
FDA-SSN-134448 Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services
6/16/26, 11:24 AM Protective Clothing Blood Penetration Resistance Tester
The Food and Drug Administration's Winchester Engineering and Analytical Center Laboratory seeks to procure one newly manufactured Protective Clothing Blood Penetration Resistance Tester to support regulatory testing of level 4 medical gowns, with quotes due August 7 at 1:00 P.M. Central Time. The procurement is open to full and open competition with no set-aside restriction.
Place of performance is Winchester, MA 01890. The equipment must meet 11 minimum technical requirements: four independent working positions capable of simultaneous testing; automatic timer for test initiation and termination; accommodation of 70 mm × 70 mm minimum test samples; minimum test pressure of 13.8 kPa; real-time pressure monitoring with automatic adjustment; operation using compressed air; autoclavable test cells; 60 mL fluid processing capacity per cell; integrated touchscreen user interface; and capability to perform testing per ASTM F1670 and ASTM F1671/F1671M standards. The equipment must be turn-key, newly manufactured (not used or refurbished), and include all hardware, software, installation supplies, comprehensive operations and maintenance manuals, complete installation labor, on-site training, Installation Qualification and Operational Qualification documentation and services, and a minimum one-year warranty with phone and email technical support. Delivery occurs within 120 days from award on an FOB Point Destination basis with all shipping, handling, installation, and inside delivery included in price. The contract type is Commercial Item-Firm Fixed Price with Net 30 payment terms. Quoters must provide technical specifications demonstrating compliance with all minimum requirements, submit an Accessibility Conformance Report addressing Section 508 standards, include their UEI number, and hold prices firm through September 30. Award goes to the lowest priced technically acceptable responsible quoter. The NAICS code is 334516, Analytical Laboratory Instrument Manufacturing, with a Small Business Size Standard of 1,000 employees.
75F40126Q134448 Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services
7/31/26, 3:30 PM