GASKET, DOOR, SURGICA

The contract requires the supply of six door gaskets for surgical instrument sterilizers, identified by NSN 6530-01-588-2449 and manufacturer part number 61301607692 from Getinge USA Sales, LLC. Each gasket is specified as red stripe silicone and must meet Regulation 880.6880 Class II requirements, including compliance with FDA 510(k) submissions and applicable marketing, labeling, and GMP standards. Performance is due within 20 days of order award, with delivery designated FOB destination to FPO Zip 96632. All units must be packaged commercially per the procurement document and in strict accordance with ASTM D3951, though DLA’s Master List of Technical and Quality Requirements takes precedence. Each complete unit must be sealed in a protective container, and all shipping containers must be commercially suitable to ensure safe transit at the lowest cost, including export packaging when necessary. Palletization must follow RP001 DLA Packaging Requirements, and all materials must be marked per Medical Marking Standard No. 1, which supersedes MIL-STD-129. Hazardous materials, if any, require compliance with the Hazard Communication Standard (29 CFR 1910.1200) and submission of Safety Data Sheets prior to award; failure to do so renders the offer ineligible. Additive manufacturing is prohibited unless prior approval is obtained from the contracting officer and Engineering Support Activity. The contract incorporates cybersecurity requirements under DFARS 252.240-7997 NIST SP 800-171 and mandates adherence to FAR clauses on safeguarding covered defense information, whistleblower rights, disclosure limitations, and prohibitions on restricted arbitration agreements. Invoicing and payment processing must occur through WAWF using approved submission methods, and contractors must maintain current representations in SAM, including UEI and CAGE codes. The procurement is not set aside for small businesses, is subject to DPAS DX/DO ratings, and requires compliance with the Berry Amendment and Buy American Act. Offers must include bidder and manufacturer details and adhere to the May 27, 2026 submission deadline.