APPLICATOR, DISPOSABLE

This contract specifies the procurement of disposable applicators featuring a maximum length of 4.000 inches, a nominal shaft diameter of 0.200 inches, and a round tip with either a rayon or cotton head treated with Providone-Iodine. The items are classified as Class I medical devices regulated by the FDA, requiring compliance with registration, listing, labeling, or Good Manufacturing Practices even though a 510(k) is not required. The unit of issue is a package containing 75 individual applicators, and the procurement is designated as a MEPSEP item with no substitutions permitted. All medical acquisitions must adhere to strict packaging and marking standards, specifically requiring compliance with Medical Marking Standard No. 1. Each unit must be contained in a sealed container to prevent damage and shipped in suitable commercial exterior containers to ensure safe delivery to the destination. The contract requires delivery within 20 days to the destination, where both inspection and acceptance will occur. Bidders are responsible for specifying the source and part number being supplied, and the procurement is subject to specific DLA technical and quality requirements.