
Medline Industries, Inc.
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SensiCare PI and SensiCare PI Micro Surgical Gloves is an FDA 510(k)-cleared medical device (K193217) manufactured by Medline Industries, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 5, 2020. Regulation: 8.