A-A-30188 Mask, Surgical (Sub-Micron)This commercial item description describes a disposable surgical mask, suitable for use by medical personnel in operating rooms and other areas where it is necessary to maintain protective aseptic technique, provide a barrier to blood and body fluids, provide filtration of sub-micron particles, and provide a tight face fit. Uses include, but are not limited to , laser surgery where exposure to laser plums is expected, surgical procedures that generate blood aerosols, and areas in the hospital where masks providing a tight face fit are desirable.

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A-A-30188

Tests. Tests shall be conducted to determine compliance with this commercial item description requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics.

Sampling for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105, with an AQL of 2.5 (percent defective)and an inspection level of S-1.The unit of product for examination purposes shall be one respirator as specified in this description.

Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units, providing they fall within the tolerances specified using conversion tables contained in the latest revision of Federal Standard 376, and all other requirements of this document are met.

If a product is manufactured to metric dimensions and those dimensions exceed the tolerances specified in the inch-pound units, a request should be made to the contracting officer to determine if the product is acceptable.

The contracting officer has the option of accepting or rejecting the product.

Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description, and conforms to the producer's own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to the 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 the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereafter. 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.