BRACE, ANKLE

Ankle brace, medium black, designed with superior materials to support natural body movement, functions as a dynamic stabilizer for either ankle and is intended to be worn inside footwear. It is not made with natural rubber latex and is sized for men’s shoe sizes 9.5 to 11 and women’s shoe sizes 11 to 12.5. The unit of issue is each, with a contract quantity of eight units required for delivery. The product is regulated by the FDA as a Class I device under regulation 890.3475 and must comply with applicable marketing requirements including registration, labeling, and good manufacturing practices, though a 510(k) may or may not be required. Packaging must adhere to Medical Marking Standard No. 1, superseding MIL-STD-129, with each unit sealed in a protective container and shipped in commercial exterior packaging suitable for safe carrier delivery at the lowest cost. Marking, palletization, and packaging must follow DLA procurement guidelines and commercial standards as specified. Delivery is required within five days FOB destination to Camp Pendleton, California, via fastest traceable means—parcel post is prohibited. The contract number is SPE2DS-26-T-038Z, with a required delivery date of May 4, 2026, and the NSN is 6515-01-699-6640. The item is supplied by SCHOOL HEALTH CORP under part number 1035313 or CRUZE DISTRIBUTION, LLC under part number AY-81-102BK-SG, and the purchase price is $8.00 per unit for a total of $64.00.