FDA-Device2017-11-29Class II
Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
Medline Industries Inc
Hazard
Possible open seal on top portion of the package. Could cause breach of sterility.
Sold states
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.
Affected count
8,000 units
Manufactured in
Three Lakes Drive, N/A, Northfield, IL, United States
Products
Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0162-2018Don't want to check this manually?
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