AMENDMENT 7 - ANSI/AAMI Level 2 Disposable Isolation Gowns   8

Background
The solicitation is for the purchase of domestically manufactured ANSI/AAMI PB70 Level 2 disposable medical Isolation Gowns used in healthcare settings. The Strategic National Stockpile (SNS) managed by the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. The mission of the SNS is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters or other emerging infectious disease agents.

Work Details
The contractor is required to deliver ANSI/AAMI PB70 Level 2 disposable medical Isolation Gowns that comply with specific technical requirements outlined in the Statement of Work (SOW). The gowns must be non-sterile, disposable, single-use, not made with natural rubber latex, and meet ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities. They should also meet FDA’s general device labeling requirements per 21 CFR Part 801 and ASTM F3352-19 Section 11.1 and 11.2 Labeling Requirements.
The required isolation gowns are to be provided in large and extra-large sizes with specific dimensions and must be packaged with up to 10 gowns per bag and no more than 100 individual gowns in total per outer carton/case.

Period of Performance
The period of performance is anticipated to total 24 months from the date of award with a base period of 24 months and an option period of 12 months.

Place of Performance
The products shall be shipped FOB Destination to a Government designated location within the continental United States (CONUS).