Protective Clothing Blood Penetration Resistance Tester
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), on behalf of the Center for Devices and Radiological Health (CDRH), is conducting market research through a Sources Sought announcement for a Protective Clothing Blood Penetration Resistance Tester. This equipment is needed to support future regulatory testing of level 4 medical gowns, aiming to automate and improve consistency in viral penetration testing. Responses are due June 23, 2026.
Scope of Work
The FDA requires one (1) Protective Clothing Blood Penetration Resistance Tester for its Winchester Engineering and Analytical Center Laboratory (WEAC). Key requirements include:
- Technical: Four independent working positions, automatic timer, accommodates 70mm x 70mm samples, capable of 13.8 kPa pressure, real-time pressure monitoring, compressed air operation, autoclavable test cells, 60 mL fluid capacity per cell, integrated touchscreen, and compliance with ASTM F1670 and ASTM F1671/F1671M standards.
- System: Must be newly manufactured, a turn-key solution (including all hardware, software, and components), delivered with all necessary supplies for installation/startup, and include operations/maintenance manuals (hard copy/electronic).
- Services: Contractor shall provide on-site installation, demonstration of performance specifications, operator training/familiarization, Installation Qualification (IQ) and Operational Qualification (OQ) documentation and services.
- Support: Systems must be warranted for not less than one (1) year from FDA acceptance, including troubleshooting, immediate access to replacement parts, and phone/email technical support.
- Delivery: FOB Destination to Winchester, MA, within 120 days of award, including shipping, handling, installation, IQ/OQ, and inside delivery.
Contract & Timeline
- Type: Sources Sought / Market Research
- Set-Aside: Primarily seeking small business sources under NAICS Code 334516 (Analytical Laboratory Instrument Manufacturing, 1,000 employees size standard). Other than small businesses and vendors offering domestic products are also encouraged to respond.
- Response Due: June 23, 2026, by 1:00 PM Central Time
- Published: June 16, 2026
- Place of Performance: U.S. Food and Drug Administration, Winchester Engineering and Analytical Center, 109 Holton Street, Winchester, MA 01890.
Response Requirements
Respondents must submit capability statements demonstrating regular engagement in selling similar products/services. Submissions should include:
- Business name, UEI, address, website, size status, and point of contact.
- Past performance information for similar products/services.
- Descriptive literature, brochures, and sufficient technical information to confirm compliance with requirements.
- Identification of Best in Class (BIC) contracts, GSA Schedule contracts, or AbilityOne contracts if applicable.
- Subcontracting opportunities for small businesses (if a large business).
- Standard commercial warranty and payment terms.
- Place of product manufacture for Buy American Act considerations.
- Informational pricing is desired.
Additional Notes
This is for market research only and is not a solicitation or request for proposal. The Government is not obligated to award a contract or pay for information provided. Responses must demonstrate capability, not merely affirm it, and should not include proprietary or confidential information. Weblinks will not be opened or viewed.