FDA-Device2020-02-12Class II
ROYALSILK LARGE, Gown. Item Code 9518
Cardinal Health
Hazard
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Sold states
Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
Affected count
7,659,634 total units
Manufactured in
1350 Bridge Dr, N/A, Waukegan, IL, United States
Products
ROYALSILK LARGE, Gown. Item Code 9518
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1022-2020Don't want to check this manually?
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