FDA-Device2015-10-28Class II
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Cardinal Health
Hazard
Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.
Sold states
Nationwide Distribution.
Affected count
34 cases.
Manufactured in
1300 Waukegan Rd, N/A, Waukegan, IL, United States
Products
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0133-2016Don't want to check this manually?
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