Saturday, February 27, 2021 3:19:53 PM
One of their vendors, WildCAT PPE, received a 510(K) as the only domestic PPE manufacturer for FDA approved full back gowns.
Tremont Strategies Group LLC filed a lobbying registration on Dec. 17, 2020 to represent Unifire, effective Dec. 15, 2020. Original Filing: 301227875.xml
Issue(s) they said they’d lobby about: Manufacture and distribution of personal protective equipment for the HHS/ASPR Strategic National Stockpile; other issues related to domestic manufacturing..
https://wildcatcorps.com/weve-secured-510k-clearance-for-our-full-back-gown-heres-what-that-means-for-american-made-ppe/
https://edition.pagesuite-professional.co.uk/html5/reader/production/default.aspx?pubname=&edid=af52503d-0ed2-4c9d-b6a9-1d790a21b533 (pg 162-163)
The product that received 510(K) clearance, our AAMI Level 3 full back isolation gown, is used primarily to protect frontline healthcare workers from contracting diseases. It guards against COVID-19, but it’s also critical for other conditions that will outlast this pandemic. We’re the first U.S. PPE manufacturer to secure clearance, and it will enable us to continue serving America’s medical workers into the future.
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