FDA-Device2023-10-18Class II

NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

Ansell Healthcare Products LLC
Hazard

Some surgical glove sterile pouches were not completely sealed.

Sold states
Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.
Affected count
378
Manufactured in
2301 Robb Dr, N/A, Reno, NV, United States
Products
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0097-2024

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