APPLICATOR, POVIDONE

The contract solicitation SPE2DS-26-T-110Y seeks the procurement of 500-count packages of sterile, disposable applicators impregnated with povidone iodine solution containing 1 percent titratable iodine, an antiseptic, identified by NSN 6510-01-170-1177. Each applicator consists of a 5.5 by 1.75-inch sealed packet with a 4-inch swabstick and must be packaged individually and shipped in commercial exterior containers suitable for safe transit under common carrier standards. Packaging and marking must comply with Medical Marking Standard No. 1, superseding MIL-STD-129, and all units must be labeled in accordance with FDA regulations as a Class I medical device under Regulation 880.6025, requiring registration, listing, and GMP compliance though no 510(k) submission is needed. The item is regulated by the FDA and subject to domestic material restrictions under the Berry Amendment and Buy American Act, requiring disclosure if non-domestic materials are used. Delivery is required within 20 days of award with a fixed required delivery date of June 2, 2026, to the consignee at Bell, California, and shipment must be via traceable means excluding parcel post. All submissions must be made through the DLA Internet Bid Board System by June 8, 2026, and offerors must be registered in SAM.gov with valid representations and certifications, including socioeconomic status and compliance with prohibitions on covered defense telecommunications equipment. The contract incorporates numerous Federal Acquisition Regulation clauses addressing cybersecurity, whistleblower protections, disposal of hazardous materials, cyber incident reporting, and safeguarding covered defense information, with special emphasis on the Safeguarding Covered Defense Information clause issued in May 2024. Invoicing and payment must be processed through the Wide Area Workflow system, requiring both invoices and receiving reports unless exempt, and contractors must comply with the Hazard Communication Standard for hazardous materials, though labeling under the Federal Food, Drug and Cosmetics Act satisfies this requirement. Technical and quality requirements are referenced through R and I numbers in the DLA Master List of Technical and Quality Requirements, and removal of government identification from non-accepted supplies is mandated. The procurement is not a small business set-aside and is governed by deviation 2026-00048 regarding certified cost or pricing data requirements, with potential classification