APPLICATOR, DISPOSAB

The contract calls for the procurement of disposable medical applicators with an overall length not to exceed 4.000 inches and a nominal shaft diameter of 0.200 inches, featuring a round tip and either a rayon or cotton head impregnated with Providone-Iodine. These applicators are designated under NSN 6515-01-316-9295 and are regulated by the FDA as a Class I device under regulation 880.6025, requiring compliance with FDA marketing requirements including registration, listing, labeling, and GMPs, even though a 510(k) submission is not mandated. The units must be packaged in sealed individual containers that protect against damage and packed in commercial exterior shipping containers suitable for safe transport by common carriers at the lowest cost to the destination at Eglin AFB, Florida. All packaging and marking must conform to Medical Marking Standard No. 1, which replaces MIL-STD-129, and preparation must adhere to MIL-STD-2073-1E. The unit of issue is a package (PG), with each package containing 75 units, and the total quantity required is two packages, meaning 150 individual applicators. Delivery is required within 20 days of award, FOB destination, with inspection and acceptance occurring at the point of delivery. The contract incorporates technical and quality requirements from the DLA Master List, mandates removal of government identification from non-accepted supplies, and requires strict adherence to cybersecurity protocols including safeguarding covered defense information, cyber incident reporting, and compliance with NIST SP 800-171. The contractor must comply with the Buy American Act and Berry Amendment, and may be subject to DPAS priority ratings. Invoicing and payment must be processed through the Wide Area Workflow system, with payment documentation following FAR 52.216-7 guidelines. The solicitation is not a small business set-aside, but HUBZone pricing preferences may apply, and all offerors must maintain current representations in SAM. Offerors are required to specify their source and part number, with approved suppliers including NICE-PAK, Cardinal Health, and Medline Industries. Compliance with FAR and DFARS clauses governing contractor ethics, whistleblower rights, trafficking in persons, and cybersecurity is mandatory, and failure to meet specifications may result in rejection or non-acceptance at destination.