A-A-51111
26 November 1985
COMMERCIAL ITEM DESCRIPTION
BANDAGE, GAUZE, (FINE MESH)
The General Services Administration has authorized the use of this commercial item description.
This Commercial Item Description covers a fine mesh gauze dressing.
Salient characteristics:
Shall be a sterile, disposable, fine mesh, gauze bandage 3 inches wide by 8 inches long (7.6 cm by 20.3 cm). The bandage shall be suitable for use as a wound dressin on burns, skin grafts, lacerations and various other general surgical procedures. The edges of the gauze shall be crushed to preclude raveling and fraying.
The gauze shall meet all requirements of type I Absorbent Gauze, USP. The bandage shall meet any FDA requirements for safety and toxicity applicable for invasive/implantable devices.
Testing and examination shall be conducted to determine compliance with all specification requirements. Test methods shall be suitable, accurate and reproducible.
Workmanship. The bandages shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Package (PG). Each bandage shall be individually packaged in a suitable peel-open type container which will allow aseptic handling and maintain sterility of contents until opened or damaged. Each individual bandage shall be “Z” folded. One package containing 864 individually packaged bandages, as specified, constitutes one unit.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Regulatory requirements.
Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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