MASK, ORONASAL

The Defense Logistics Agency awarded a contract to PACIFIC STAR CORPORATION (CAGE 4QNY3) for 50 units of a MASK, ORONASAL (NSN 6515-01-276-1417) under solicitation SPE2DS-26-T-228K, with a total contract value of $367.50 and an award date of July 17, 2026. The item is a universal-sized oronasal mask featuring a head strap coupling and pre-inflate cushion, designed to prevent mouth-to-mouth contact during resuscitation; it must be easy to clean and either disposable after single use or reusable for manikin training, accompanied by a pocket-sized case with illustrated instructions on the reverse. The product is regulated as a Class II medical device under FDA Regulation 868.5905 and requires a 510(k) submission along with compliance with registration, labeling, and GMP requirements. Delivery is required within 20 days after order date, with FOB destination terms to FPO, ZIP 09514, and acceptance occurs at destination per FAR 52.246-2. Packaging and marking must adhere to ASTM D3951, RP001, MIL-STD-129, and the latest edition of Medical Marking Standard No. 1, with unit packing quantity set at 1. Hazardous material handling requires compliance with the Hazard Communication Standard (29 CFR 1910.1200) and Federal Standard No. 313, and all shipments must be properly labeled and documented per these regulations. The contract incorporates multiple FAR and DFARS clauses addressing safety, compliance, and administrative requirements, including prohibitions on hexavalent chromium and toxic hazardous materials, restrictions on mandatory arbitration agreements, export control of items, electronic submission of payment requests via WAWF, and notification of potential safety issues. Payment must be submitted through WAWF using prescribed formats—invoice and receiving report for fixed-price line items—with specific documentation rules applying based on item type. Contractors are required to maintain current SAM registrations and submit all relevant socioeconomic representations for small business, HUBZone, WOSB, and SDVOSB statuses. The contract includes deviation 2026-00038 applied to multiple labor and employment clauses, such as equal opportunity for workers with disabilities, combating trafficking