APPLICATOR, DISPOSAB

The contract pertains to the procurement of disposable applicators with an overall length not exceeding 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 povidone-iodine, intended for medical use and regulated by the FDA as a Class I device under regulation 880.6025. Each unit must be individually sealed in a protective container and packed in commercial-grade shipping containers suitable for safe transport via common carriers at the lowest cost to the specified delivery point, with all packaging and marking strictly adhering to Medical Marking Standard No. 1, which replaces MIL-STD-129. The unit of issue is the package, with each package containing 75 units, and delivery is required within five days after order placement, FOB destination, with zero tolerance for quantity variance. The material must be marked in strict compliance with MMS No. 1, and compliance with MIL-STD-2073-1E for preservation and packaging is mandatory. The solicitation requires bidders to specify their source and part number, and approved manufacturers include NICE-PAK PRODUCTS INC, MEDLINE INDUSTRIES, LP, and CARDINAL HEALTH 200, LLC, with specific part numbers provided. All submissions must be made electronically through the DIBBS portal by the stated deadline, and the contract enforces compliance with numerous FAR and DFARS clauses addressing sustainable products, hazardous materials, cybersecurity safeguards, employment eligibility, trafficking in persons, and electronic invoicing via WAWF. Although a 510(k) is not required, the product must meet FDA registration, listing, labeling, and GMP requirements. The government will inspect and accept the product at the delivery point, and contractors must maintain proper documentation and certifications, including UEI and CAGE codes, and represent small business status where applicable. Payment will be processed exclusively through WAWF, and no substitutions or alternate products are permitted under the MEPSEP designation.